The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Hewlett Packard M2475b Codemaster 100 Defibrillator/monitor.
Device ID | K950483 |
510k Number | K950483 |
Device Name: | HEWLETT PACKARD M2475B CODEMASTER 100 DEFIBRILLATOR/MONITOR |
Classification | Pacemaker, Cardiac, External Transcutaneous (non-invasive) |
Applicant | HEWLETT-PACKARD CO. 1700 SOUTH BAKER ST. Mcminnville, OR 97128 |
Contact | Nancy Winn |
Correspondent | Nancy Winn HEWLETT-PACKARD CO. 1700 SOUTH BAKER ST. Mcminnville, OR 97128 |
Product Code | DRO |
CFR Regulation Number | 870.5550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-02-03 |
Decision Date | 1995-05-22 |