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 |