The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Models M1722a, M1723a, M1724a Defibrillators.
Device ID | K915757 |
510k Number | K915757 |
Device Name: | MODELS M1722A, M1723A, M1724A DEFIBRILLATORS |
Classification | Pacemaker, Cardiac, External Transcutaneous (non-invasive) |
Applicant | HEWLETT-PACKARD CO. 1700 SOUTH BAKER ST. Mcminnville, OR 97128 |
Contact | Monica Ferrante |
Correspondent | Monica Ferrante 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 | 1991-12-23 |
Decision Date | 1992-07-30 |