The following data is part of a premarket notification filed by Forma Scientific, Inc. with the FDA for Forma Ch/p Gas Processor.
Device ID | K812826 |
510k Number | K812826 |
Device Name: | FORMA CH/P GAS PROCESSOR |
Classification | Bath, Incubators/water, All |
Applicant | FORMA SCIENTIFIC, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JTQ |
CFR Regulation Number | 866.2540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-10-08 |
Decision Date | 1981-10-23 |