Micronaire Iso-Hood Max 5UV

FDA 510(k) K912142 · Micronaire Corp.

Substantially Equivalent

510(k) numberK912142

Submission

Device name
Micronaire Iso-Hood Max 5UV
Applicant
Micronaire Corp.
Greenville, SC, US
Received
May 14, 1991
Decision date
October 30, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
EAZ – Light, Operating, Dental
Device class
Class I (low risk)
Regulation
21 CFR 872.4630
Specialty
Dental

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K923462DelightEAZ · Traditional Planmeca USA, Inc.12/21/1992SE
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K902685Defiance Model Fus 336EAZ · Traditional Defiance Electronics, Inc.09/17/1990SE

Questions and answers

When was Micronaire Iso-Hood Max 5UV cleared by the FDA?

Micronaire Iso-Hood Max 5UV (K912142) received a 510(k) decision of Substantially Equivalent on October 30, 1991, 169 days after the submission was received.

What is the product code of K912142?

The FDA product code is EAZ – Light, Operating, Dental, a Class I (low risk) device regulated under 21 CFR 872.4630.