510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K828543Substantially Equivalent

Unknown

General Electric Co., Schenectady NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K828543 is the FDA 510(k) clearance record for UNKNOWN, cleared for General Electric Co. on . FDA records list 256 510(k) clearances for General Electric Co., from to . As of , FDA records show no recalls naming K828543.

Clearance record

Decision date
Received
(775 days to decision)
Review panel
Unknown
Applicant
General Electric Co. 1 River Rd., Schenectady NY
Third party review
No