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-400d.
| Device ID | K912280 |
| 510k Number | K912280 |
| Device Name: | BI-TEMP TEMPERATURE MONITOR, MODEL TM-400D |
| 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 | 1991-10-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20695085001475 | K912280 | 000 |
| 30695085001465 | K912280 | 000 |
| 30695085001441 | K912280 | 000 |
| 30695085001434 | K912280 | 000 |
| 30695085001410 | K912280 | 000 |
| 30695085001403 | K912280 | 000 |
| 30695085001397 | K912280 | 000 |
| 30695085001380 | K912280 | 000 |
| 30695085002974 | K912280 | 000 |
| 30695085001489 | K912280 | 000 |
| 30695085001519 | K912280 | 000 |
| 30695085001526 | K912280 | 000 |
| 30695085001694 | K912280 | 000 |
| 30695085001649 | K912280 | 000 |
| 30695085001625 | K912280 | 000 |
| 30695085001601 | K912280 | 000 |
| 30695085001564 | K912280 | 000 |
| 30695085001557 | K912280 | 000 |
| 30695085001540 | K912280 | 000 |
| 30695085001533 | K912280 | 000 |
| 30695085000093 | K912280 | 000 |