The following data is part of a premarket notification filed by Respiratory Support Products, Inc. with the FDA for Bi-temp Temperature Monitor,model Tm-300d.
| Device ID | K913082 |
| 510k Number | K913082 |
| Device Name: | BI-TEMP TEMPERATURE MONITOR,MODEL TM-300D |
| 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 | 1991-05-23 |
| Decision Date | 1991-12-11 |