Atlas FDA

MAYFIELD TABLE-ELECTRIC

FDA 510(k) clearance K851021 · decided 1985-05-21

Clearance details

K-number
K851021
Device name
MAYFIELD TABLE-ELECTRIC
Applicant
Ohio Medical Instrument Co., Inc.
Decision
Substantially Equivalent
Date received
1985-03-12
Decision date
1985-05-21
Days to decision
70 days
Clearance type
Traditional
Product code
GDC
Device class
1
Regulation number
878.4960
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Cincinnati, OH, 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
QUANTUM 3080SP SURGICAL TABLE (K971390)STERIS Corporation1997-05-15
MOBILE OPERATING TABLE 1132.01 (K970807)Stierlen-Maquet AG1997-03-14
DURA-BOARD ARMBOARD (K964273)Allen Medical Systems, Inc.1997-01-08
SKYTRON ELITE 3500 TABLE (K940616)Skytron, Div. the Kmw Group, Inc.1994-06-13
MIDMARK MAGNUM GENERAL SURGICAL TABLE (K934744)Midmark Corp.1994-03-28
MDT/SHAMPAINE MODEL 4900B SURGICAL TABLE (K914758)Mdt Corp., Inc.1991-12-19
MDT/SHAMPAINE MODEL 4900E SURGICAL TABLE (K915393)Mdt Corp., Inc.1991-12-17
OPER. TABLE FOR PERCUTAN. TRANS. CORONARY ANGIO. (K883613)Stierlen-Maquet AG1988-09-15
MOBILE OPERATING TABLE FOR ORL MICROSURGERY (K853720)Carl Zeiss, Inc.1985-10-18
SKYTRON ELITE 6000 & 6001 SURGICAL TABLES (K853480)Skytron, Div. the Kmw Group, Inc.1985-09-12
TRAUMA TABLE (K853535)Xre Corp.1985-09-11
SKYTRON ELITE 7000 MICRO-SURGERY TABLE (K851830)Skytron, Div. the Kmw Group, Inc.1985-05-17

Recalls involving this device

No recalls on record reference this clearance.