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FDA 510(k)

BIOSELF TM 110

K-Number: K843699 · 1984-12-04

ApplicantBioself, Inc.
Decision Date1984-12-04
Product CodeLHD
DecisionSubstantially Equivalent

Device Summary

BIOSELF TM 110 is the device name listed in this FDA 510(k) record. The listed applicant is Bioself, Inc.. It received FDA 510(k) clearance on 1984-12-04 under 510(k) number K843699. The device is classified under product code LHD. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOSELF TM 110?

BIOSELF TM 110 is a medical device that received FDA 510(k) clearance on 1984-12-04. The listed applicant is Bioself, Inc.. The 510(k) number is K843699.

When did BIOSELF TM 110 receive FDA 510(k) clearance?

BIOSELF TM 110 received FDA 510(k) clearance on 1984-12-04, under 510(k) number K843699.

Who is the listed applicant for BIOSELF TM 110?

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 TM 110?

The FDA product code for BIOSELF TM 110 is LHD.

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.

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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.

K904211BIOSELF 2000 FERTILITY INDICATORK823209BIOSELF 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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