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FDA 510(k)

SUNTECH MODELS 3001 ALLSTAR & 3401 GALAXY

K-Number: K850660 · 1985-03-01

ApplicantSuntech USA, Inc.
Decision Date1985-03-01
Product CodeFTC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SUNTECH MODELS 3001 ALLSTAR & 3401 GALAXY is the device name listed in this FDA 510(k) record. The listed applicant is Suntech USA, Inc.. It received FDA 510(k) clearance on 1985-03-01 under 510(k) number K850660. 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 SUNTECH MODELS 3001 ALLSTAR & 3401 GALAXY?

SUNTECH MODELS 3001 ALLSTAR & 3401 GALAXY is a medical device that received FDA 510(k) clearance on 1985-03-01. The listed applicant is Suntech USA, Inc.. The 510(k) number is K850660.

When did SUNTECH MODELS 3001 ALLSTAR & 3401 GALAXY receive FDA 510(k) clearance?

SUNTECH MODELS 3001 ALLSTAR & 3401 GALAXY received FDA 510(k) clearance on 1985-03-01, under 510(k) number K850660.

Who is the listed applicant for SUNTECH MODELS 3001 ALLSTAR & 3401 GALAXY?

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

What is the FDA product code for SUNTECH MODELS 3001 ALLSTAR & 3401 GALAXY?

The FDA product code for SUNTECH MODELS 3001 ALLSTAR & 3401 GALAXY is FTC.

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Official Source

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