The following data is part of a premarket notification filed by Progressive Dynamics, Inc. with the FDA for Life-air 1000 Hypothermic Treatment System.
Device ID | K914382 |
510k Number | K914382 |
Device Name: | LIFE-AIR 1000 HYPOTHERMIC TREATMENT SYSTEM |
Classification | System, Thermal Regulating |
Applicant | PROGRESSIVE DYNAMICS, INC. 507 INDUSTRIAL RD. Marshall, MI 49068 -1796 |
Contact | David Dykehouse |
Correspondent | David Dykehouse 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 | 1991-10-01 |
Decision Date | 1992-04-21 |