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FDA 510(k)

RELAX STRESS REDUCTION SYS

K-Number: K841128 · 1984-07-16

ApplicantSynapse Software Corp.
Decision Date1984-07-16
Product CodeHCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

RELAX STRESS REDUCTION SYS is the device name listed in this FDA 510(k) record. The listed applicant is Synapse Software Corp.. It received FDA 510(k) clearance on 1984-07-16 under 510(k) number K841128. The device is classified under product code HCC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RELAX STRESS REDUCTION SYS?

RELAX STRESS REDUCTION SYS is a medical device that received FDA 510(k) clearance on 1984-07-16. The listed applicant is Synapse Software Corp.. The 510(k) number is K841128.

When did RELAX STRESS REDUCTION SYS receive FDA 510(k) clearance?

RELAX STRESS REDUCTION SYS received FDA 510(k) clearance on 1984-07-16, under 510(k) number K841128.

Who is the listed applicant for RELAX STRESS REDUCTION SYS?

The FDA 510(k) record lists Synapse Software Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RELAX STRESS REDUCTION SYS?

The FDA product code for RELAX STRESS REDUCTION SYS is HCC.

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Official Source

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

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