FDA 510(k) · Instromedix
K945476: HEARTHWATCH III(TM) (Instromedix, Inc.)
Instromedix, Inc. received FDA 510(k) K945476 for HEARTHWATCH III(TM), with a decision date of Nov 9, 1995 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K945476 |
|---|---|
| Pathway | 510(k) |
| Applicant | Instromedix, Inc. |
| Device name | HEARTHWATCH III(TM) |
| Product code | DXH: Transmitters And Receivers, Electrocardiograph, Telephone |
| Regulation (21 CFR) | 870.2920 |
| Device class | Class 2 |
| Date received | Nov 8, 1994 |
| Decision date | Nov 9, 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 DXH is "Transmitters And Receivers, Electrocardiograph, Telephone", class 2, 21 CFR 870.2920.
Our labels for filtering: claim ECG, sensor Wrist PPG. These are heuristics, not FDA fields.