The following data is part of a premarket notification filed by Cardiac Resucitator Corp. with the FDA for Heart*aid 1000.
Device ID | K870622 |
510k Number | K870622 |
Device Name: | HEART*AID 1000 |
Classification | Automated External Defibrillators (non-wearable) |
Applicant | CARDIAC RESUCITATOR CORP. 12244 S.W. GARDEN PLACE Portland, OR 97223 |
Contact | John L Karpowicz |
Correspondent | John L Karpowicz CARDIAC RESUCITATOR CORP. 12244 S.W. GARDEN PLACE Portland, OR 97223 |
Product Code | MKJ |
CFR Regulation Number | 870.5310 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-02-12 |
Decision Date | 1987-04-10 |