510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K837494Substantially Equivalent

Baby Light Meter

Rocky Mountain Medical Corp., Montrose CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K837494 is the FDA 510(k) clearance record for BABY LIGHT METER, cleared for Rocky Mountain Medical Corp. on . FDA records list 9 510(k) clearances for Rocky Mountain Medical Corp., from to . As of , FDA records show no recalls naming K837494.

Clearance record

Decision date
Received
(56 days to decision)
Review panel
Unknown
Applicant
Rocky Mountain Medical Corp. 20 Apollo Rd., Montrose CO
Third party review
No