The following data is part of a premarket notification filed by Birtcher Corp. with the FDA for Cardiopac Defibrillator 444.
| Device ID | K844103 |
| 510k Number | K844103 |
| Device Name: | CARDIOPAC DEFIBRILLATOR 444 |
| Classification | Dc-defibrillator, Low-energy, (including Paddles) |
| Applicant | BIRTCHER CORP. 4501 N. ARDEN DR. P.O. BOX 4399 El Monte, CA 91731 |
| Product Code | LDD |
| CFR Regulation Number | 870.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-23 |
| Decision Date | 1985-01-18 |