The following data is part of a premarket notification filed by Reimers Engineering, Inc. with the FDA for Ves-temp Model Vt1 Monoplace Cool/heat System.
Device ID | K873546 |
510k Number | K873546 |
Device Name: | VES-TEMP MODEL VT1 MONOPLACE COOL/HEAT SYSTEM |
Classification | System, Thermal Regulating |
Applicant | REIMERS ENGINEERING, INC. 6314-K GRAVEL AVE. Alexandria, VA 22310 |
Contact | Reimers, P.e. |
Correspondent | Reimers, P.e. REIMERS ENGINEERING, INC. 6314-K GRAVEL AVE. Alexandria, VA 22310 |
Product Code | DWJ |
CFR Regulation Number | 870.5900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-01 |
Decision Date | 1988-01-29 |