The following data is part of a premarket notification filed by Cardiac Resucitator Corp. with the FDA for Modified Heart*aid 97 Auto. External Defibrillator.
| Device ID | K871569 |
| 510k Number | K871569 |
| Device Name: | MODIFIED HEART*AID 97 AUTO. EXTERNAL DEFIBRILLATOR |
| Classification | Pacemaker, Cardiac, External Transcutaneous (non-invasive) |
| 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 | DRO |
| CFR Regulation Number | 870.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-24 |
| Decision Date | 1987-06-08 |