The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Hp M1175a, M1176a, Component Monitoring System.
Device ID | K941811 |
510k Number | K941811 |
Device Name: | HP M1175A, M1176A, COMPONENT MONITORING SYSTEM |
Classification | Electrocardiograph |
Applicant | HEWLETT-PACKARD CO. 175 WYMAN ST. Waltham, MA 02451 -1223 |
Contact | Ray Stelting |
Correspondent | Ray Stelting HEWLETT-PACKARD CO. 175 WYMAN ST. Waltham, MA 02451 -1223 |
Product Code | DPS |
CFR Regulation Number | 870.2340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-04-12 |
Decision Date | 1994-05-17 |