Atlas FDA

Disposable Pressure Manometer (DPM)

FDA 510(k) clearance K143148 · decided 2015-08-11

Clearance details

K-number
K143148
Device name
Disposable Pressure Manometer (DPM)
Applicant
Westmed, Inc.
Decision
Substantially Equivalent
Date received
2014-11-03
Decision date
2015-08-11
Days to decision
281 days
Clearance type
Traditional
Product code
CAP
Device class
2
Regulation number
868.2600
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Tucson, AZ, 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
SINGLE USE MANOMETER (K201666)Flexicare Medical Limited.2020-11-13
VORTRAN APM-Plus (K182292)Vortran Medical Technology 1, Inc.2019-09-18
NS 120P-TRS Airway Pressure Gauge (K180510)Instrumentation Industries, Inc.2019-05-01
NAPA LP-15 Airway Pressure Monitor (K172284)Drw Medical, LLC2018-02-09
VORTRAN Manometer (K153733)Vortran Medical Technology 1, Inc.2016-09-16
DISPOSABLE PRESSURE MANOMETER (K140370)Besmed Health Business Corp2014-06-19
GIO DIGITAL PRESSURE GUAGES (K122627)Galemed Corp.2013-08-22
MANOMETER (K122077)Intersurgical, Inc.2013-01-10
VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETER (K120118)Ventlab Corp.2012-05-24
VORTRAN AIRWAY PRESSURE MONITOR (VAPM)-ADULT, VORTRAN AIRWAY PRESSURE MONITOR (VAPM)- PEDIATRIC (K103639)Vortran Medical Technology 1, Inc.2011-09-15
PRESSURE MANOMETER (K110119)Neoforce Group, Inc.2011-06-10
VENTIPLUS DISPOSABLE MANOMETER 0-60 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0-20 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0 (K102377)A Plus Medical2010-11-18

Recalls involving this device

No recalls on record reference this clearance.