Atlas FDA

NEWPORT HT50 VENTILATOR WITH HUMIDIFIER HT50-H, NEWPORT HT50 VENTILATOR WITHOUT HUMIDIFIER, HT50-H1, NEWPORT HT50 VENTIL

FDA 510(k) clearance K992133 · decided 2000-08-04

Clearance details

K-number
K992133
Device name
NEWPORT HT50 VENTILATOR WITH HUMIDIFIER HT50-H, NEWPORT HT50 VENTILATOR WITHOUT HUMIDIFIER, HT50-H1, NEWPORT HT50 VENTIL
Applicant
Newport Medical Instruments, Inc.
Decision
Substantially Equivalent - Subject to Tracking Reg.
Date received
1999-06-23
Decision date
2000-08-04
Days to decision
408 days
Clearance type
Traditional
Product code
CBK
Device class
2
Regulation number
868.5895
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Costa Mesa, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
V24-00400-29 cable, an accessory to the Newport HT50 ventilator. The V24-00400-29 cable is recall (Z-1041-2012)Flight Medical Ltd.2012-02-21
Newport HT50 Ventilator. Model #HT50 H1-B The device is intended to provide continuous or recall (Z-2295-2011)Newport Medical Instruments Inc2011-05-26
Newport HT50 Ventilator. Model No. HT50-H, HT50-HB, HT50-H1, and HT50-H1B. The device is i recall (Z-2382-2011)Newport Medical Instruments Inc2011-05-26
Newport HT50 Ventilator (all Models) recall (Z-1192-2007)Newport Medical Instruments Inc2007-09-19
Newport HT50 All Purpose Ventilator recall (Z-1375-05)Newport Medical Instruments Inc2005-08-17