RS Biotech Galaxy 'R' CO2 Incubator

FDA 510(k) K003184 · Zander Medical Supplies, Inc.

Substantially Equivalent

510(k) numberK003184

Submission

Device name
RS Biotech Galaxy 'R' CO2 Incubator
Applicant
Zander Medical Supplies, Inc.
Vero Beach, FL, US
Received
October 11, 2000
Decision date
November 20, 2000
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MQG – Accessory, Assisted Reproduction
Device class
Class II (moderate risk)
Regulation
21 CFR 884.6120
Specialty
Obstetrics/Gynecology

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Questions and answers

When was RS Biotech Galaxy 'R' CO2 Incubator cleared by the FDA?

RS Biotech Galaxy 'R' CO2 Incubator (K003184) received a 510(k) decision of Substantially Equivalent on November 20, 2000, 40 days after the submission was received.

What is the product code of K003184?

The FDA product code is MQG – Accessory, Assisted Reproduction, a Class II (moderate risk) device regulated under 21 CFR 884.6120.