The following data is part of a premarket notification filed by Waltham Div. Hewlett Packard with the FDA for Models M1175a & M1176a Component Monitoring System.
| Device ID | K882609 |
| 510k Number | K882609 |
| Device Name: | MODELS M1175A & M1176A COMPONENT MONITORING SYSTEM |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | WALTHAM DIV. HEWLETT PACKARD 175 WYMAN ST. Waltham, MA 02254 |
| Contact | Nicholas Poly |
| Correspondent | Nicholas Poly WALTHAM DIV. HEWLETT PACKARD 175 WYMAN ST. Waltham, MA 02254 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-27 |
| Decision Date | 1989-01-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838010819 | K882609 | 000 |