The following data is part of a premarket notification filed by North American Technical Services Corp. with the FDA for External Pacemaker Analyzer, Model Pmt 100.
| Device ID | K961582 |
| 510k Number | K961582 |
| Device Name: | EXTERNAL PACEMAKER ANALYZER, MODEL PMT 100 |
| Classification | Analyzer, Pacemaker Generator Function |
| Applicant | NORTH AMERICAN TECHNICAL SERVICES CORP. 30 NORTHPORT RD. Sound Beach, NY 11789 -1734 |
| Contact | Richard C Lanzillotto |
| Correspondent | Richard C Lanzillotto NORTH AMERICAN TECHNICAL SERVICES CORP. 30 NORTHPORT RD. Sound Beach, NY 11789 -1734 |
| Product Code | DTC |
| CFR Regulation Number | 870.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-24 |
| Decision Date | 1996-11-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B3359500 | K961582 | 000 |
| B3359600 | K961582 | 000 |