Atlas FDA

VORTRAN APM-Plus

FDA 510(k) clearance K182292 · decided 2019-09-18

Clearance details

K-number
K182292
Device name
VORTRAN APM-Plus
Applicant
Vortran Medical Technology 1, Inc.
Decision
Substantially Equivalent
Date received
2018-08-23
Decision date
2019-09-18
Days to decision
391 days
Clearance type
Traditional
Product code
CAP
Device class
2
Regulation number
868.2600
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Sacramento, CA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

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RecordFirmDate
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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.