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FDA 510(k)

CLIMAX

K-Number: K991049 · 1999-06-15

ApplicantMedilatex Sdn. Bhd.
Decision Date1999-06-15
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CLIMAX is the device name listed in this FDA 510(k) record. The listed applicant is Medilatex Sdn. Bhd.. It received FDA 510(k) clearance on 1999-06-15 under 510(k) number K991049. The device is classified under product code HIS. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLIMAX?

CLIMAX is a medical device that received FDA 510(k) clearance on 1999-06-15. The listed applicant is Medilatex Sdn. Bhd.. The 510(k) number is K991049.

When did CLIMAX receive FDA 510(k) clearance?

CLIMAX received FDA 510(k) clearance on 1999-06-15, under 510(k) number K991049.

Who is the listed applicant for CLIMAX?

The FDA 510(k) record lists Medilatex Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLIMAX?

The FDA product code for CLIMAX is HIS.

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Related Devices (Code: HIS)

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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