The following data is part of a premarket notification filed by Life Recovery Systems Hd, Llc with the FDA for Thermosuit System.
| Device ID | K061023 |
| 510k Number | K061023 |
| Device Name: | THERMOSUIT SYSTEM |
| Classification | Hyperthermia Monitor |
| Applicant | LIFE RECOVERY SYSTEMS HD, LLC 29 ANTHONY TERRACE Durham, CT 06422 |
| Contact | Paul A Tenthorey |
| Correspondent | Paul A Tenthorey LIFE RECOVERY SYSTEMS HD, LLC 29 ANTHONY TERRACE Durham, CT 06422 |
| Product Code | NZE |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-13 |
| Decision Date | 2006-09-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851936007119 | K061023 | 000 |
| 10851936007079 | K061023 | 000 |
| 08511936007126 | K061023 | 000 |
| 00851936007126 | K061023 | 000 |
| 00851936007003 | K061023 | 000 |
| 00851936007010 | K061023 | 000 |
| 00851936007027 | K061023 | 000 |
| 00851936007034 | K061023 | 000 |
| 00851936007041 | K061023 | 000 |
| 00851936007058 | K061023 | 000 |
| 00851936007065 | K061023 | 000 |
| 00851936007072 | K061023 | 000 |
| 00851936007089 | K061023 | 000 |
| 00851936007096 | K061023 | 000 |
| 08511936007010 | K061023 | 000 |