The following data is part of a premarket notification filed by Hewlett-packard Gmbh with the FDA for Hewlett-packard Models M1001b Ecg M1002b Ecg/respiration Plug-in Modules.
| Device ID | K973437 |
| 510k Number | K973437 |
| Device Name: | HEWLETT-PACKARD MODELS M1001B ECG M1002B ECG/RESPIRATION PLUG-IN MODULES |
| Classification | Electrocardiograph |
| Applicant | HEWLETT-PACKARD GMBH SCHICKARD STRASSE 4 BOEBLINGEN Wuerttemberg, DE 71034 |
| Contact | Egon Pfeil |
| Correspondent | Egon Pfeil HEWLETT-PACKARD GMBH SCHICKARD STRASSE 4 BOEBLINGEN Wuerttemberg, DE 71034 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-10 |
| Decision Date | 1997-12-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838012486 | K973437 | 000 |
| 00884838012479 | K973437 | 000 |