FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

AIRWAYS

K Number: K820709 · Decision Jun 25, 1982
Classifications
1
FEI Numbers
229
Registration Numbers
229
Same Product Code
56
Applicant Total
7
Review Days
99

Research this 510(k) in seconds

The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

Free to try · every answer cites its records

Basic Information

Device Name
AIRWAYS
K Number
K820709
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
868.5110
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Applicant
Seven Harvest Intl. Import & Export
Date Received
March 18, 1982
Decision Date
June 25, 1982
Product Code
CAE
Advisory Committee
Anesthesiology
Review Advisory Committee
AN
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
CAE Airway, Oropharyngeal, Anesthesiology

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (CAE), ordered by most recent decision date.

View all

Other Clearances by Seven Harvest Intl. Import & Export

K Number Device Name
K940793 DOUBLE TRACH SWIVEL CONNECTOR
K823506 NASAL CANNULA
K823141 OXYGEN MASKS
K823142 OXYGEN TUBINGS
K823143 BUBBLE HUMIDIFIERS
K813074 CONNECTORS & ADAPTERS