The following data is part of a premarket notification filed by Progressive Dynamics, Inc. with the FDA for Life-air 1000 Hypothermic Therapy System.
| Device ID | K952329 |
| 510k Number | K952329 |
| Device Name: | LIFE-AIR 1000 HYPOTHERMIC THERAPY SYSTEM |
| Classification | System, Thermal Regulating |
| Applicant | PROGRESSIVE DYNAMICS, INC. 507 INDUSTRIAL RD. Marshall, MI 49068 -1796 |
| Contact | William F Lohness |
| Correspondent | William F Lohness PROGRESSIVE DYNAMICS, INC. 507 INDUSTRIAL RD. Marshall, MI 49068 -1796 |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-18 |
| Decision Date | 1996-01-17 |