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FDA 510(k)

BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR

K-Number: K000702 · 2000-06-07

ApplicantFresenius Medical Care North America
Decision Date2000-06-07
Product CodeFIB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius Medical Care North America. It received FDA 510(k) clearance on 2000-06-07 under 510(k) number K000702. 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 BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR?

BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR is a medical device that received FDA 510(k) clearance on 2000-06-07. The listed applicant is Fresenius Medical Care North America. The 510(k) number is K000702.

When did BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR receive FDA 510(k) clearance?

BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR received FDA 510(k) clearance on 2000-06-07, under 510(k) number K000702.

Who is the listed applicant for BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR?

The FDA 510(k) record lists Fresenius Medical Care North America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR?

The FDA product code for BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR is FIB.

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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.

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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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