Atlas FDA

OXYGEN COUPLER, AIR COUPLER & VACUUM COUPLER

FDA 510(k) clearance K901961 · decided 1990-08-14

Clearance details

K-number
K901961
Device name
OXYGEN COUPLER, AIR COUPLER & VACUUM COUPLER
Applicant
Medical Fittings, Inc.
Decision
Substantially Equivalent
Date received
1990-05-01
Decision date
1990-08-14
Days to decision
105 days
Clearance type
Traditional
Product code
BYX
Device class
1
Regulation number
868.5860
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Northampton, PA, 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
OXYGEN SUPPLY TUBING, MODEL 1115 (K011134)Hudson Respiratory Care, Inc.2001-06-13
NORTH STATE PLASTICS AEROSOL TEE (K955656)North State Plastics, Inc.1996-03-06
GAS SAMPLING INTERFACES (K943110)Coast Medical, Inc.1994-08-19
BUSSE PLASTIC TUBING CONNECTORS AND ACCESSORIES (K935835)Busse Hospital Disposables, Inc.1994-01-12
MF CHEMETRON STYLE MEDICAL GAS WALL OUTLETS (K931033)Medical Fittings, Inc.1993-06-01
MF OHMEDA STYLE MEDICAL GAS WALL OUTLETS (K931043)Medical Fittings, Inc.1993-06-01
OXYGEN TUBING, 81503 (K913422)Specialty Packaging Producs, Inc.1992-01-30
HEX, QUAD, OR RAIL BLOCK MANIFOLD ACCESSORIES (K914980)Medical Fittings, Inc.1992-01-21
OHMEDA STYLE CHECK UNITS (FEMALE COUPLERS) (K912763)Medical Fittings, Inc.1991-10-15
VARIOUS MALE QUICK CONNECTS. (K905091)Medical Fittings, Inc.1991-03-04
SCHRADER OXYGEN/AIR VAC&NITR-OXIDE MALE QUICK CONN (K905094)Medical Fittings, Inc.1990-11-20
OXYGEN, AIR, VACUUM & NITROUS-OXIDE COUPLERS (K904757)Medical Fittings, Inc.1990-10-31

Recalls involving this device

No recalls on record reference this clearance.