The following data is part of a premarket notification filed by Siemens Burdick, Inc. with the FDA for Dc200 Defibrillator.
| Device ID | K910634 |
| 510k Number | K910634 |
| Device Name: | DC200 DEFIBRILLATOR |
| Classification | Dc-defibrillator, Low-energy, (including Paddles) |
| Applicant | SIEMENS BURDICK, INC. 15 PLUMB ST. Miltoon, WI 53563 |
| Contact | Paul E Appel |
| Correspondent | Paul E Appel SIEMENS BURDICK, INC. 15 PLUMB ST. Miltoon, WI 53563 |
| Product Code | LDD |
| CFR Regulation Number | 870.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-13 |
| Decision Date | 1991-07-24 |