Atlas FDA

PRESSURE GAUGE

FDA 510(k) clearance K923800 · decided 1993-02-26

Clearance details

K-number
K923800
Device name
PRESSURE GAUGE
Applicant
Innovations For Mechanical Ventilation, Inc.
Decision
Substantially Equivalent
Date received
1992-07-29
Decision date
1993-02-26
Days to decision
212 days
Clearance type
Traditional
Product code
BSK
Device class
2
Regulation number
868.5750
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
New City, NY, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.