Suzanne

FDA 510(k) K990565 · Nellcor Puritan Bennett, Inc.

Substantially Equivalent

510(k) numberK990565

Submission

Device name
Suzanne
Applicant
Nellcor Puritan Bennett, Inc.
Minneapolis, MN, US
Received
February 22, 1999
Decision date
August 18, 1999
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MNR – Ventilatory Effort Recorder
Device class
Class II (moderate risk)
Regulation
21 CFR 868.2375
Specialty
Anesthesiology

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Questions and answers

When was Suzanne cleared by the FDA?

Suzanne (K990565) received a 510(k) decision of Substantially Equivalent on August 18, 1999, 177 days after the submission was received.

What is the product code of K990565?

The FDA product code is MNR – Ventilatory Effort Recorder, a Class II (moderate risk) device regulated under 21 CFR 868.2375.