The following data is part of a premarket notification filed by Respiratory Support Products, Inc. with the FDA for Adap-temp Temperature Sensor Adapter.
Device ID | K921190 |
510k Number | K921190 |
Device Name: | ADAP-TEMP TEMPERATURE SENSOR ADAPTER |
Classification | Thermometer, Electronic, Clinical |
Applicant | RESPIRATORY SUPPORT PRODUCTS, INC. 2552 MCGAW AVE. Irvine, CA 92614 |
Contact | Gordon Shigezawa |
Correspondent | Gordon Shigezawa RESPIRATORY SUPPORT PRODUCTS, INC. 2552 MCGAW AVE. Irvine, CA 92614 |
Product Code | FLL |
CFR Regulation Number | 880.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-03-09 |
Decision Date | 1993-03-09 |