FDA 510(k) FDA class 1 Substantially Equivalent 🇬🇧 United Kingdom

OLYMPUS MOBILE CHAIR/COUCH

K Number: K962528 · Decision Dec 12, 1996
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
1
Applicant Total
6
Review Days
168

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Basic Information

Device Name
OLYMPUS MOBILE CHAIR/COUCH
K Number
K962528
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
878.4950
Medical Specialty
General, Plastic Surgery
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Keymed (Medical & Industrial Equipment), Ltd.
Date Received
June 27, 1996
Decision Date
December 12, 1996
Product Code
FZK
Advisory Committee
General, Plastic Surgery
Review Advisory Committee
RA
Third Party
N

Classifications

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

Product Code Device Name
FZK Chair, Surgical, Non-Electrical

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (FZK), ordered by most recent decision date.

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Other Clearances by Keymed (Medical & Industrial Equipment), Ltd.

K Number Device Name
K100899 OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2
K011725 OLYMPUS SUCTION PUMP, MODEL KV-5
K000948 OLYMPUS ENDOSCOPIC FLUSHING PUMP MODEL OFP-1
K930852 OLYMPUS SUCTION PUMP MODEL KV-4
K881478 MODIFIED KEYMED FLEXIBLE ESOPHAGEAL DILATORS