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FDA 510(k)

GENESIS BLS

K-Number: K983643 · 1998-10-29

ApplicantO-Two Systems Intl., Inc.
Decision Date1998-10-29
Product CodeBTL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

GENESIS BLS is the device name listed in this FDA 510(k) record. The listed applicant is O-Two Systems Intl., Inc.. It received FDA 510(k) clearance on 1998-10-29 under 510(k) number K983643. The device is classified under product code BTL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENESIS BLS?

GENESIS BLS is a medical device that received FDA 510(k) clearance on 1998-10-29. The listed applicant is O-Two Systems Intl., Inc.. The 510(k) number is K983643.

When did GENESIS BLS receive FDA 510(k) clearance?

GENESIS BLS received FDA 510(k) clearance on 1998-10-29, under 510(k) number K983643.

Who is the listed applicant for GENESIS BLS?

The FDA 510(k) record lists O-Two Systems Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GENESIS BLS?

The FDA product code for GENESIS BLS is BTL.

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 O-Two Systems Intl., 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.

K991195CAREVENT BLS, CAREVENT BLS+, CAREVENT ALS, CAREVENT ALS+, AND CAREVENT ATVK983857AUTOVENT 1500K983785AUTOVENT 1000K983705EMT RESUSCITATORK960995CPR BIO-BARRIER FACESHEILDK940712PPM III

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Related Devices (Code: BTL)

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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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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