The following data is part of a premarket notification filed by Thermotek, Inc. with the FDA for Thermotek H-300.
| Device ID | K945853 |
| 510k Number | K945853 |
| Device Name: | THERMOTEK H-300 |
| Classification | Pack, Hot Or Cold, Water Circulating |
| Applicant | THERMOTEK, INC. 3330 EARHART DR., SUITE 212 Carrollton, TX 75006 |
| Contact | John F Skinner |
| Correspondent | John F Skinner THERMOTEK, INC. 3330 EARHART DR., SUITE 212 Carrollton, TX 75006 |
| Product Code | ILO |
| CFR Regulation Number | 890.5720 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-31 |
| Decision Date | 1995-10-05 |