FDA 510(k)

DISETRONIC RAPID SUBCUTANEOUS INFUSION SET AND DISTERONIC RAPID D SUBCUTANEOUS INFUSION SET

K-Number: K003977 · 2001-02-15

Decision Date2001-02-15

Product CodeFPA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

DISETRONIC RAPID SUBCUTANEOUS INFUSION SET AND DISTERONIC RAPID D SUBCUTANEOUS INFUSION SET is the device name listed in this FDA 510(k) record. The listed applicant is Disetronic Medical Systems AG. It received FDA 510(k) clearance on 2001-02-15 under 510(k) number K003977. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISETRONIC RAPID SUBCUTANEOUS INFUSION SET AND DISTERONIC RAPID D SUBCUTANEOUS INFUSION SET?

DISETRONIC RAPID SUBCUTANEOUS INFUSION SET AND DISTERONIC RAPID D SUBCUTANEOUS INFUSION SET is a medical device that received FDA 510(k) clearance on 2001-02-15. The listed applicant is Disetronic Medical Systems AG. The 510(k) number is K003977.

When did DISETRONIC RAPID SUBCUTANEOUS INFUSION SET AND DISTERONIC RAPID D SUBCUTANEOUS INFUSION SET receive FDA 510(k) clearance?

DISETRONIC RAPID SUBCUTANEOUS INFUSION SET AND DISTERONIC RAPID D SUBCUTANEOUS INFUSION SET received FDA 510(k) clearance on 2001-02-15, under 510(k) number K003977.

Who is the listed applicant for DISETRONIC RAPID SUBCUTANEOUS INFUSION SET AND DISTERONIC RAPID D SUBCUTANEOUS INFUSION SET?

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

What is the FDA product code for DISETRONIC RAPID SUBCUTANEOUS INFUSION SET AND DISTERONIC RAPID D SUBCUTANEOUS INFUSION SET?

The FDA product code for DISETRONIC RAPID SUBCUTANEOUS INFUSION SET AND DISTERONIC RAPID D SUBCUTANEOUS INFUSION SET is FPA.

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Other records listing Disetronic Medical Systems AG as applicant

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Related Devices (Code: FPA)

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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.