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FDA 510(k)

NEOGUARD REFLECTOR

K-Number: K853794 · 1985-10-16

ApplicantCas Medical Systems, Inc.
Decision Date1985-10-16
Product CodeFMT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NEOGUARD REFLECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Cas Medical Systems, Inc.. It received FDA 510(k) clearance on 1985-10-16 under 510(k) number K853794. The device is classified under product code FMT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEOGUARD REFLECTOR?

NEOGUARD REFLECTOR is a medical device that received FDA 510(k) clearance on 1985-10-16. The listed applicant is Cas Medical Systems, Inc.. The 510(k) number is K853794.

When did NEOGUARD REFLECTOR receive FDA 510(k) clearance?

NEOGUARD REFLECTOR received FDA 510(k) clearance on 1985-10-16, under 510(k) number K853794.

Who is the listed applicant for NEOGUARD REFLECTOR?

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

What is the FDA product code for NEOGUARD REFLECTOR?

The FDA product code for NEOGUARD REFLECTOR is FMT.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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