The following data is part of a premarket notification filed by Netech Corp. with the FDA for Defibrillator Analyzer, Delta 1000.
| Device ID | K961595 |
| 510k Number | K961595 |
| Device Name: | DEFIBRILLATOR ANALYZER, DELTA 1000 |
| Classification | Tester, Defibrillator |
| Applicant | NETECH CORP. 30 NORTHPORT RD. Sound Beach, NY 11789 -1734 |
| Contact | Richard C Lanzillotto |
| Correspondent | Richard C Lanzillotto NETECH CORP. 30 NORTHPORT RD. Sound Beach, NY 11789 -1734 |
| Product Code | DRL |
| CFR Regulation Number | 870.5325 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-24 |
| Decision Date | 1996-10-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B3356500 | K961595 | 000 |