Autolink Body Plethysmograph

FDA 510(k) K960121 · P.K. Morgan , Ltd.

Substantially Equivalent

510(k) numberK960121

Submission

Device name
Autolink Body Plethysmograph
Applicant
P.K. Morgan , Ltd.
Kent Rainham Me8 7ed, GB
Received
January 11, 1996
Decision date
January 9, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
BZC – Calculator, Pulmonary Function Data
Device class
Class II (moderate risk)
Regulation
21 CFR 868.1880
Specialty
Anesthesiology

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Questions and answers

When was Autolink Body Plethysmograph cleared by the FDA?

Autolink Body Plethysmograph (K960121) received a 510(k) decision of Substantially Equivalent on January 9, 1997, 364 days after the submission was received.

What is the product code of K960121?

The FDA product code is BZC – Calculator, Pulmonary Function Data, a Class II (moderate risk) device regulated under 21 CFR 868.1880.