Atlas FDA

FDX SOLID STATE VIDEO CAMERA MODEL 5950

FDA 510(k) clearance K891236 · decided 1989-04-05

Clearance details

K-number
K891236
Device name
FDX SOLID STATE VIDEO CAMERA MODEL 5950
Applicant
Medical Dynamics, Inc.
Decision
Substantially Equivalent
Date received
1989-03-07
Decision date
1989-04-05
Days to decision
29 days
Clearance type
Traditional
Product code
FWD
Device class
1
Regulation number
878.4160
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Englewood, CO, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
JEDMED MICRO CCD CAMERA SYSTEM (K882166)Jedmed Instrument Co.1988-06-15
JEDMED CCD CAMERA SYSTEM (K862664)Jedmed Instrument Co.1986-07-30
JEDMED MINI-MOS VIDEO CAMERA (K862145)Jedmed Instrument Co.1986-06-13
JEDMED CCD-02 VIDEO CAMERA SYSTEM (K862034)Jedmed Instrument Co.1986-06-09

Recalls involving this device

No recalls on record reference this clearance.