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FDA 510(k)

RENALAB TRANSDUCER PROTECTOR, .22 MICRON

K-Number: K812107 · 1981-08-20

ApplicantRenalab
Decision Date1981-08-20
Product CodeFIB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RENALAB TRANSDUCER PROTECTOR, .22 MICRON is the device name listed in this FDA 510(k) record. The listed applicant is Renalab. It received FDA 510(k) clearance on 1981-08-20 under 510(k) number K812107. The device is classified under product code FIB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RENALAB TRANSDUCER PROTECTOR, .22 MICRON?

RENALAB TRANSDUCER PROTECTOR, .22 MICRON is a medical device that received FDA 510(k) clearance on 1981-08-20. The listed applicant is Renalab. The 510(k) number is K812107.

When did RENALAB TRANSDUCER PROTECTOR, .22 MICRON receive FDA 510(k) clearance?

RENALAB TRANSDUCER PROTECTOR, .22 MICRON received FDA 510(k) clearance on 1981-08-20, under 510(k) number K812107.

Who is the listed applicant for RENALAB TRANSDUCER PROTECTOR, .22 MICRON?

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

What is the FDA product code for RENALAB TRANSDUCER PROTECTOR, .22 MICRON?

The FDA product code for RENALAB TRANSDUCER PROTECTOR, .22 MICRON is FIB.

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.

Related Devices (Code: FIB)

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.

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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