DMR/CO2 Combo Kti

FDA 510(k) K960468 · Nellcor Puritan Bennett, Inc.

Unknown

510(k) numberK960468

Submission

Device name
DMR/CO2 Combo Kti
Applicant
Nellcor Puritan Bennett, Inc.
Pleasanton, CA, US
Received
February 1, 1996
Decision date
April 26, 1996
Decision
Unknown (SESK)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
BTM – Ventilator, Emergency, Manual (Resuscitator)
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5915
Specialty
Anesthesiology
Life-sustaining
Yes

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Questions and answers

When was DMR/CO2 Combo Kti cleared by the FDA?

DMR/CO2 Combo Kti (K960468) received a 510(k) decision of Unknown on April 26, 1996, 85 days after the submission was received.

What is the product code of K960468?

The FDA product code is BTM – Ventilator, Emergency, Manual (Resuscitator), a Class II (moderate risk) device regulated under 21 CFR 868.5915.