The following data is part of a premarket notification filed by Dynatech/nevada, Inc. with the FDA for Impulse 3000 Defibrillator Analyzer.
Device ID | K934254 |
510k Number | K934254 |
Device Name: | IMPULSE 3000 DEFIBRILLATOR ANALYZER |
Classification | Tester, Defibrillator |
Applicant | DYNATECH/NEVADA, INC. 555 THIRTEENTH ST. N.W. Washington, DC 20004 -1109 |
Contact | Howard M Holstein |
Correspondent | Howard M Holstein DYNATECH/NEVADA, INC. 555 THIRTEENTH ST. N.W. Washington, DC 20004 -1109 |
Product Code | DRL |
CFR Regulation Number | 870.5325 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-08-31 |
Decision Date | 1993-11-23 |