FDA PMA FDA Class 2 Approved 🇺🇸 United States

Monitor, Airway Pressure (Includes Gauge And/Or Alarm)

PMA: N83074 · Supplement: S004 · Decision Sep 12, 1990
Classifications
1
FEI Numbers
55
Registration Numbers
55

Basic Information

Device Name
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
Trade Name
NON-ABSORBABLE BLACK SILK SUTURE
PMA Number
N83074
Supplement Number
S004
Device Class
FDA Class 2
Product Code
CAP
Generic Name
MONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND/OR ALARM)
Regulation Number
868.2600
Medical Specialty
Anesthesiology
Advisory Committee
General, Plastic Surgery
Decision
Approved
Decision Code
APPR
Decision Date
September 12, 1990
Date Received
July 31, 1990
Supplement Type
Normal 180 Day Track
Supplement Reason
Change Design/Components/Specifications/Material
Expedited Review
N

Classifications

This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

Product Code Device Name
CAP Monitor, Airway Pressure (Includes Gauge And/Or Alarm)