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 |