Beckman MMC II Metabolic Meas. Cart

FDA 510(k) K820905 · Beckman Instruments, Inc.

Substantially Equivalent

510(k) numberK820905

Submission

Device name
Beckman MMC II Metabolic Meas. Cart
Applicant
Beckman Instruments, Inc.
Mchenry, IL, US
Received
April 1, 1982
Decision date
May 14, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
BZL – Computer, Oxygen-Uptake
Device class
Class II (moderate risk)
Regulation
21 CFR 868.1730
Specialty
Anesthesiology

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Questions and answers

When was Beckman MMC II Metabolic Meas. Cart cleared by the FDA?

Beckman MMC II Metabolic Meas. Cart (K820905) received a 510(k) decision of Substantially Equivalent on May 14, 1982, 43 days after the submission was received.

What is the product code of K820905?

The FDA product code is BZL – Computer, Oxygen-Uptake, a Class II (moderate risk) device regulated under 21 CFR 868.1730.