The following data is part of a premarket notification filed by Hogan & Hartson with the FDA for Impulse 4000 Defibrillator/transcutaneous Pacer Analyzer.
| Device ID | K941404 |
| 510k Number | K941404 |
| Device Name: | IMPULSE 4000 DEFIBRILLATOR/TRANSCUTANEOUS PACER ANALYZER |
| Classification | Tester, Defibrillator |
| Applicant | HOGAN & HARTSON 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109 |
| Contact | Howard M Holstein |
| Correspondent | Howard M Holstein HOGAN & HARTSON 555 THIRTEENTH STREET, 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 | 1994-03-23 |
| Decision Date | 1994-06-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850540007133 | K941404 | 000 |