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FDA 510(k)

BETATRON I AMBULATORY INSULIN PUMP

K-Number: K833306 · 1983-11-28

ApplicantCardiac Pacemakers, Inc.
Decision Date1983-11-28
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BETATRON I AMBULATORY INSULIN PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Cardiac Pacemakers, Inc.. It received FDA 510(k) clearance on 1983-11-28 under 510(k) number K833306. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BETATRON I AMBULATORY INSULIN PUMP?

BETATRON I AMBULATORY INSULIN PUMP is a medical device that received FDA 510(k) clearance on 1983-11-28. The listed applicant is Cardiac Pacemakers, Inc.. The 510(k) number is K833306.

When did BETATRON I AMBULATORY INSULIN PUMP receive FDA 510(k) clearance?

BETATRON I AMBULATORY INSULIN PUMP received FDA 510(k) clearance on 1983-11-28, under 510(k) number K833306.

Who is the listed applicant for BETATRON I AMBULATORY INSULIN PUMP?

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

What is the FDA product code for BETATRON I AMBULATORY INSULIN PUMP?

The FDA product code for BETATRON I AMBULATORY INSULIN PUMP is FRN.

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Related Devices (Code: FRN)

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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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