The following data is part of a premarket notification filed by Life Enhancement Technologies, Llc. with the FDA for Mark Vii Thermoregulation Assist System.
| Device ID | K900355 |
| 510k Number | K900355 |
| Device Name: | MARK VII THERMOREGULATION ASSIST SYSTEM |
| Classification | Pack, Hot Or Cold, Water Circulating |
| Applicant | LIFE ENHANCEMENT TECHNOLOGIES, LLC. MEDICAL & RADIATION TECHNOLOGY 6319 MASSACHUSETTS AVENUE Bethesda, MD 20816 |
| Contact | Roger Schneider |
| Correspondent | Roger Schneider LIFE ENHANCEMENT TECHNOLOGIES, LLC. MEDICAL & RADIATION TECHNOLOGY 6319 MASSACHUSETTS AVENUE Bethesda, MD 20816 |
| Product Code | ILO |
| CFR Regulation Number | 890.5720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-25 |
| Decision Date | 1990-02-15 |