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FDA 510(k)

DISETRONIC D-MODEM

K-Number: K961975 · 1997-01-30

ApplicantDisetronic Medical Systems
Decision Date1997-01-30
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

DISETRONIC D-MODEM is the device name listed in this FDA 510(k) record. The listed applicant is Disetronic Medical Systems. It received FDA 510(k) clearance on 1997-01-30 under 510(k) number K961975. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking Reg..

Frequently Asked Questions

What is the DISETRONIC D-MODEM?

DISETRONIC D-MODEM is a medical device that received FDA 510(k) clearance on 1997-01-30. The listed applicant is Disetronic Medical Systems. The 510(k) number is K961975.

When did DISETRONIC D-MODEM receive FDA 510(k) clearance?

DISETRONIC D-MODEM received FDA 510(k) clearance on 1997-01-30, under 510(k) number K961975.

Who is the listed applicant for DISETRONIC D-MODEM?

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

What is the FDA product code for DISETRONIC D-MODEM?

The FDA product code for DISETRONIC D-MODEM is FRN.

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Other records listing Disetronic Medical Systems as applicant

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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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