The following data is part of a premarket notification filed by Seamed Corp. with the FDA for Sea Med Ddd Pacing System Analyzer.
| Device ID | K851900 |
| 510k Number | K851900 |
| Device Name: | SEA MED DDD PACING SYSTEM ANALYZER |
| Classification | Analyzer, Pacemaker Generator Function |
| Applicant | SEAMED CORP. 4500 - 150TH AVE. N.E. Redmond, WA 98052 |
| Contact | Bengt Svensson |
| Correspondent | Bengt Svensson SEAMED CORP. 4500 - 150TH AVE. N.E. Redmond, WA 98052 |
| Product Code | DTC |
| CFR Regulation Number | 870.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-30 |
| Decision Date | 1985-07-19 |