FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

ENDOTRACHAEL TUBE AND HOLDER

K Number: K760998 · Decision Nov 19, 1976
Classifications
1
FEI Numbers
132
Registration Numbers
132
Same Product Code
240
Applicant Total
8
Review Days
11

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
ENDOTRACHAEL TUBE AND HOLDER
K Number
K760998
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
868.5730
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Applicant
Mcgaw Respiratory Therapy
Date Received
November 8, 1976
Decision Date
November 19, 1976
Product Code
BTR
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
BTR Tube, Tracheal (W/Wo Connector)

Similar 510(k) Clearances

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

View all

Other Clearances by Mcgaw Respiratory Therapy

K Number Device Name
K771550 MRT DISPENSOR
K771516 CAPILLARY SAMPLE LINE
K770665 VALVE, PRESSURE, DEMAND
K770286 VENTILATOR BREATHING CIRCUIT
K761300 NEBULIZER CONTROL UNIT
K761298 PRE-FILLED DISPOSABLE NEBULIZER
K761299 DISPOSABLE NEBULIZER