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FDA 510(k)

SUNJET MODELS 240/280

K-Number: K853679 · 1985-10-01

ApplicantSunjet Manufacturer, Inc.
Decision Date1985-10-01
Product CodeFTC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SUNJET MODELS 240/280 is the device name listed in this FDA 510(k) record. The listed applicant is Sunjet Manufacturer, Inc.. It received FDA 510(k) clearance on 1985-10-01 under 510(k) number K853679. The device is classified under product code FTC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUNJET MODELS 240/280?

SUNJET MODELS 240/280 is a medical device that received FDA 510(k) clearance on 1985-10-01. The listed applicant is Sunjet Manufacturer, Inc.. The 510(k) number is K853679.

When did SUNJET MODELS 240/280 receive FDA 510(k) clearance?

SUNJET MODELS 240/280 received FDA 510(k) clearance on 1985-10-01, under 510(k) number K853679.

Who is the listed applicant for SUNJET MODELS 240/280?

The FDA 510(k) record lists Sunjet Manufacturer, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUNJET MODELS 240/280?

The FDA product code for SUNJET MODELS 240/280 is FTC.

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Official Source

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