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FDA 510(k)

VIVA

K-Number: K011480 · 2001-05-24

ApplicantRichter Rubber Technology Sdn. Bhd.
Decision Date2001-05-24
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

VIVA is the device name listed in this FDA 510(k) record. The listed applicant is Richter Rubber Technology Sdn. Bhd.. It received FDA 510(k) clearance on 2001-05-24 under 510(k) number K011480. 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 VIVA?

VIVA is a medical device that received FDA 510(k) clearance on 2001-05-24. The listed applicant is Richter Rubber Technology Sdn. Bhd.. The 510(k) number is K011480.

When did VIVA receive FDA 510(k) clearance?

VIVA received FDA 510(k) clearance on 2001-05-24, under 510(k) number K011480.

Who is the listed applicant for VIVA?

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

What is the FDA product code for VIVA?

The FDA product code for VIVA is HIS.

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

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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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