510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
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K827858Substantially Equivalent

Model 835 Spot Film Device

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

K827858 is the FDA 510(k) clearance record for MODEL 835 SPOT FILM DEVICE, 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 K827858.

Clearance record

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