FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

DGH A-SAN PROBE HOLDER

K Number: K900162 · Decision Feb 16, 1990
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
28
Applicant Total
92
Review Days
35

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Basic Information

Device Name
DGH A-SAN PROBE HOLDER
K Number
K900162
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
884.5250
Medical Specialty
Obstetrics/Gynecology
Decision
Substantially Equivalent
Applicant
Jedmed Instrument Co.
Date Received
January 12, 1990
Decision Date
February 16, 1990
Product Code
HDR
Advisory Committee
Obstetrics/Gynecology
Review Advisory Committee
OB
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
HDR Cap, Cervical

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K944032 VIDEO SCOPE SYSTEM (LARYNGOSCOPE)
K950925 JEDMED LARYNGEAL SCOPE
K953457 JEDMED SPECTRUM ENT CABINET
K950785 HORTMANN AIRMATIC AIR CALORIC STIMULATOR
K950078 MICROFLOW IRRIGATION SYSTEM
K944671 VIDEO SCOPE SYSTEM (NASOPHARYNGOSCOPE {FLEXIBLE OR RIGID})
K944031 VIDEO SCOPE SYSTEM (OTOSCOPE)
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