The following data is part of a premarket notification filed by Western Medical Equipment Corp. with the FDA for Tmo-1000, Tmo-3000, Tmo-10,000 Non-invas. Thermo..
| Device ID | K871529 |
| 510k Number | K871529 |
| Device Name: | TMO-1000, TMO-3000, TMO-10,000 NON-INVAS. THERMO. |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | WESTERN MEDICAL EQUIPMENT CORP. 2140 NORTH 107TH ST. P.O. BOX 309 Lafayette, CO 80026 |
| Contact | Robert A Strieby |
| Correspondent | Robert A Strieby WESTERN MEDICAL EQUIPMENT CORP. 2140 NORTH 107TH ST. P.O. BOX 309 Lafayette, CO 80026 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-20 |
| Decision Date | 1987-10-22 |