510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K863987Substantially Equivalent

Bi-Temp Temperature Monitor

Respiratory Support Products, Inc., Costa Mesa CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863987 is the FDA 510(k) clearance record for BI-TEMP TEMPERATURE MONITOR, cleared for Respiratory Support Products, Inc. on . FDA records list 27 510(k) clearances for Respiratory Support Products, Inc., from to . As of , FDA records show no recalls naming K863987.

Clearance record

Decision date
Received
(35 days to decision)
Review panel
Unknown
Applicant
Respiratory Support Products, Inc. 3183-D Airway Ave., Costa Mesa CA
Third party review
No