Atlas FDA

MXR-2000 FLOWMETER

FDA 510(k) clearance K923781 · decided 1993-06-10

Clearance details

K-number
K923781
Device name
MXR-2000 FLOWMETER
Applicant
Porter Instrument Co., Inc.
Decision
Substantially Equivalent
Date received
1992-07-28
Decision date
1993-06-10
Days to decision
317 days
Clearance type
Traditional
Product code
CAX
Device class
1
Regulation number
868.2340
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Washington, D.C., DC, 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
OHMEDA - LOW FLOW FLOWMETER (K910316)Ohmeda Medical1991-04-12
FR6000 FLOWMETER (K884973)Key Instruments1989-01-17
SERIES D FLOWMETER (K872718)Puritan Bennett Corp.1987-08-05
CLASSIC (TM) 200 OXYGEN FLOWMETER (K871452)The Timeter Group1987-06-22
AIRCO 2000 SERIES FLOWMETERS (K862797)Airco, Inc.1986-08-08
SELECT FLOWMETER (K854067)Precision Medical, Inc.1985-10-29
OXYGEN DELIVERY MEASURING DEVICE (K851288)Bar-Dix, Inc.1985-09-03
PRESSURE RELIEF ADAPTOR (K850559)Precision Medical, Inc.1985-04-25
FLOWMETER, BACKPRESSURE COMPENSATED, THORPE TUBE (K850560)Precision Medical, Inc.1985-04-17
RECON-2 FLOW CONTROLLER (K834260)Precision Metering, Inc.1984-01-10
PRESET FLOWMETER (K812419)Timeter Instrument Corp.1981-09-21
TIMETER-PRODUCED PURITAN BENNETT AIR ADP (K812183)Timeter Instrument Corp.1981-08-18

Recalls involving this device

RecordFirmDate
Bag Tee Assembly Model P1407A . An accessory to the dental flowmeter which has a connectio recall (Z-0228-2009)Porter Instrument Co Inc2008-10-31