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FDA 510(k)

PREGNANCY (W) EDGE

K-Number: K821836 · 1982-07-30

Decision Date1982-07-30
Product CodeQSB
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

PREGNANCY (W) EDGE is the device name listed in this FDA 510(k) record. The listed applicant is Body Therapeutics, Inc.. It received FDA 510(k) clearance on 1982-07-30 under 510(k) number K821836. The device is classified under product code QSB. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PREGNANCY (W) EDGE?

PREGNANCY (W) EDGE is a medical device that received FDA 510(k) clearance on 1982-07-30. The listed applicant is Body Therapeutics, Inc.. The 510(k) number is K821836.

When did PREGNANCY (W) EDGE receive FDA 510(k) clearance?

PREGNANCY (W) EDGE received FDA 510(k) clearance on 1982-07-30, under 510(k) number K821836.

Who is the listed applicant for PREGNANCY (W) EDGE?

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

What is the FDA product code for PREGNANCY (W) EDGE?

The FDA product code for PREGNANCY (W) EDGE is QSB.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Other records listing Body Therapeutics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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