FDA 510(k) · Dolphin Medical
K014218: OSI MEDICAL DIGITAL DOLPHIN 3000 PULSE OXIMETER; DIGITAL DOLPHIN REUSABLE OPTICAL SENSOR, MODEL 210' (Dolphin Medical, Inc.)
Dolphin Medical, Inc. received FDA 510(k) K014218 for OSI MEDICAL DIGITAL DOLPHIN 3000 PULSE OXIMETER; DIGITAL DOLPHIN REUSABLE OPTICAL SENSOR, MODEL 210', with a decision date of Nov 7, 2002 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K014218 |
|---|---|
| Pathway | 510(k) |
| Applicant | Dolphin Medical, Inc. |
| Device name | OSI MEDICAL DIGITAL DOLPHIN 3000 PULSE OXIMETER; DIGITAL DOLPHIN REUSABLE OPTICAL SENSOR, MODEL 210' |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Dec 21, 2001 |
| Decision date | Nov 7, 2002 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
Statement 510(k) Number (if known): -KO14216 Device Name: Dolphin Medical Vovaqer Pulse Oximeter November 6,2002 Intended Use: The Dolphin Medical Voyager Pulse Oximeter and Accessories are indicated for the non-continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate (measured by an oximetry sensor). The oximeter is indicated for use with a Pocket PC (with Windows CE Operating System). (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) of CDRH, Office of Device Evaluation (ODE) o w Division of Anesthesia, General Hospital, Infection Control, and Dental Devices (DAGID) 510(k) Number: K 3 i'$zi8 Prescription Use )c OR over-the-counter Use (Per 21 CFR 801.109)
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
No predicate numbers were parsed for this record. The FDA summary, if available, names the predicate.
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code DQA is "Oximeter", class 2, 21 CFR 870.2700.
Our labels for filtering: claim SpO2 / pulse oximetry, sensor Finger PPG. These are heuristics, not FDA fields.