FDA 510(k) · Dermatology Assoc
K944395: ELCAT D-PPG, PLETHYSMOGRAPH DEVICE (Dermatology Assoc.)
Dermatology Assoc. received FDA 510(k) K944395 for ELCAT D-PPG, PLETHYSMOGRAPH DEVICE, with a decision date of May 10, 1995 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K944395 |
|---|---|
| Pathway | 510(k) |
| Applicant | Dermatology Assoc. |
| Device name | ELCAT D-PPG, PLETHYSMOGRAPH DEVICE |
| Product code | JOM: Plethysmograph, Photoelectric, Pneumatic Or Hydraulic |
| Regulation (21 CFR) | 870.2780 |
| Device class | Class 2 |
| Date received | Sep 9, 1994 |
| Decision date | May 10, 1995 |
| 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
We could not extract the indications for this record (no summary PDF was processed). Check the FDA record for its summary or statement.
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 JOM is "Plethysmograph, Photoelectric, Pneumatic Or Hydraulic", class 2, 21 CFR 870.2780.
Our labels for filtering: claim Heart rate / pulse, sensor Other. These are heuristics, not FDA fields.