510(k) K761260

ARIZONA OXYGEN TIMER DEVICE by The John Bunn Co. — Product Code BXP

K761260 is an FDA 510(k) premarket notification submitted by The John Bunn Co. for the device "ARIZONA OXYGEN TIMER DEVICE". The FDA issued a decision of Substantially Equivalent on December 16, 1976. The device falls under product code BXP (Transducer, Gas Flow), a Class I device regulated under 21 CFR 868.2885. The John Bunn Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 16, 1976
Date Received: December 8, 1976
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Transducer, Gas Flow
Device Class: Class I
Regulation Number: 868.2885
Review Panel: AN
Submission Type

Other clearances by The John Bunn Co.

K900854 — JOHN BUNN: MEDIX COMPACT TRAVELLER (April 23, 1990)
K883216 — BUNN MODEL 50 OXYGEN FLOW CONTROLLER (August 18, 1988)
K873071 — BUNN CONCENTRATOR MODEL 2100 SERIES (September 15, 1987)
K870094 — BUNN MODEL 530 ASPIRATOR (March 6, 1987)
K861435 — BUNN CONCENTRATOR MODEL 2011 WITH DEMAND VALVE (November 7, 1986)
K861199 — BUNN MODEL 22 OXYGEN FLOW CONTROLLER (August 26, 1986)
K862628 — BUNN MODEL 510 MEDICATION COMPRESSOR (August 7, 1986)
K855208 — BUNN LITE OXYGEN CONCENTRATOR (February 21, 1986)
K860060 — RX02 PLUS OXYGEN CONCENTRATOR (February 5, 1986)
K843811 — BUNN 3001 OXYGEN CONCENTRATOR (October 4, 1984)

510(k) K761260

Clearance Details

Device Classification

Other clearances by The John Bunn Co.

Other clearances for product code BXP

FDA data resources