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FDA 510(k)

BIOSELF 2000 FERTILITY INDICATOR

K-Number: K904211 · 1992-10-14

ApplicantBioself, Inc.
Decision Date1992-10-14
Product CodeLHD
DecisionSubstantially Equivalent

Device Summary

BIOSELF 2000 FERTILITY INDICATOR is the device name listed in this FDA 510(k) record. The listed applicant is Bioself, Inc.. It received FDA 510(k) clearance on 1992-10-14 under 510(k) number K904211. The device is classified under product code LHD. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOSELF 2000 FERTILITY INDICATOR?

BIOSELF 2000 FERTILITY INDICATOR is a medical device that received FDA 510(k) clearance on 1992-10-14. The listed applicant is Bioself, Inc.. The 510(k) number is K904211.

When did BIOSELF 2000 FERTILITY INDICATOR receive FDA 510(k) clearance?

BIOSELF 2000 FERTILITY INDICATOR received FDA 510(k) clearance on 1992-10-14, under 510(k) number K904211.

Who is the listed applicant for BIOSELF 2000 FERTILITY INDICATOR?

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

What is the FDA product code for BIOSELF 2000 FERTILITY INDICATOR?

The FDA product code for BIOSELF 2000 FERTILITY INDICATOR is LHD.

Related Clinical Trials

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Other records listing Bioself, 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.

K843699BIOSELF TM 110K823209BIOSELF 101

Related Devices (Code: LHD)

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.

K200163Ava Fertility TrackerAva AGK122337OVUSENSEFertility Focus, Ltd.K102499DUOFERTILITYCambridge Temperature Concepts , Ltd.K050094LADY COMP USALady Comp USAK030961MICROLIFE DIGITAL BASAL THERMOMETER, MODEL MT 1921Microlife Corp.K021978PETIT SOPHIANishitomo Co., Inc.

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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