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

BODIA BRONCH-SAF DOUBLE SWIVEL

K Number: K833373 · Decision Nov 3, 1983
Classifications
1
FEI Numbers
167
Registration Numbers
167
Same Product Code
93
Applicant Total
7
Review Days
37

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Basic Information

Device Name
BODIA BRONCH-SAF DOUBLE SWIVEL
K Number
K833373
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
868.5810
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Applicant
Sontek Industries, Inc.
Date Received
September 27, 1983
Decision Date
November 3, 1983
Product Code
BZA
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
BZA Connector, Airway (Extension)

Similar 510(k) Clearances

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

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Other Clearances by Sontek Industries, Inc.

K Number Device Name
K833372 BODIA TRACH-SAF DOUBLE SWIVEL
K833361 TUBE-TITLE
K833374 BITE-BLOCK
K813324 BODAI SWIVEL Y
K812720 BODAI PATIENT COMMUNICATOR
K811241 BODAI SUCTION -SAFE 4