The following data is part of a premarket notification filed by Rocky Mountain Medical Corp. with the FDA for Tele-temp Thermometer.
| Device ID | K890202 |
| 510k Number | K890202 |
| Device Name: | TELE-TEMP THERMOMETER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | ROCKY MOUNTAIN MEDICAL CORP. 5680 GREENWOOD PLAZA BLVD. P.O. BOX 4783 ENGLEWOOD, CO 80155 |
| Contact | J ROSENBAUM |
| Correspondent | J ROSENBAUM ROCKY MOUNTAIN MEDICAL CORP. 5680 GREENWOOD PLAZA BLVD. P.O. BOX 4783 ENGLEWOOD, CO 80155 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-17 |
| Decision Date | 1989-04-05 |