The following data is part of a premarket notification filed by Respiratory Support Products, Inc. with the FDA for Adap-temp, Model: At-100.
Device ID | K874694 |
510k Number | K874694 |
Device Name: | ADAP-TEMP, MODEL: AT-100 |
Classification | Thermometer, Electronic, Clinical |
Applicant | RESPIRATORY SUPPORT PRODUCTS, INC. 3118 ALPINE Santa Ana, CA 92704 |
Contact | Anthony V Beran |
Correspondent | Anthony V Beran RESPIRATORY SUPPORT PRODUCTS, INC. 3118 ALPINE Santa Ana, CA 92704 |
Product Code | FLL |
CFR Regulation Number | 880.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-11-13 |
Decision Date | 1988-03-01 |