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
K853541Substantially Equivalent for Some Indications

Sp 4

Robert Bosch Corp., St. James NY / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K853541 is the FDA 510(k) clearance record for SP 4, cleared for Robert Bosch Corp. on . FDA records list 21 510(k) clearances for Robert Bosch Corp., from to . As of , FDA records show no recalls naming K853541.

Clearance record

Decision date
Received
(214 days to decision)
Review panel
Unknown
Applicant
Robert Bosch Corp. Flower Field Bldg. #17, St. James NY
Third party review
No