The following data is part of a premarket notification filed by Rocky Mountain Medical Corp. with the FDA for Nursery Ambient Light Meter.
| Device ID | K860120 |
| 510k Number | K860120 |
| Device Name: | NURSERY AMBIENT LIGHT METER |
| Classification | Bed, Pediatric Open Hospital |
| Applicant | ROCKY MOUNTAIN MEDICAL CORP. 5680 S. SYRACUSE CIRCLE P.O. BOX 4783 GREENWOOD VILLAGE, CO 80111 |
| Contact | ROSENBAUM MD |
| Correspondent | ROSENBAUM MD ROCKY MOUNTAIN MEDICAL CORP. 5680 S. SYRACUSE CIRCLE P.O. BOX 4783 GREENWOOD VILLAGE, CO 80111 |
| Product Code | FMS |
| CFR Regulation Number | 880.5140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-13 |
| Decision Date | 1986-02-19 |