510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K821850Substantially Equivalent

Galtel-18

Galvanic Medical Instruments, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K821850 is the FDA 510(k) clearance record for GALTEL-18, cleared for Galvanic Medical Instruments, Inc. on . FDA records list 2 510(k) clearances for Galvanic Medical Instruments, Inc., from to . As of , FDA records show no recalls naming K821850.

Clearance record

Decision date
Received
(35 days to decision)
Review panel
Unknown
Applicant
Galvanic Medical Instruments, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No