The following data is part of a premarket notification filed by Boekel Industries, Inc. with the FDA for Anhydric Incubators, Culture Incubator.
Device ID | K831592 |
510k Number | K831592 |
Device Name: | ANHYDRIC INCUBATORS, CULTURE INCUBATOR |
Classification | Bath, Incubators/water, All |
Applicant | BOEKEL INDUSTRIES, 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 | 1983-05-17 |
Decision Date | 1983-06-16 |