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FDA 510(k)

KALLESTAD QM2/QM300 CONTROL C PACK

K-Number: K880730 · 1988-03-25

ApplicantKallestad Diag, A Div. of Erbamont, Inc.
Decision Date1988-03-25
Product CodeDCK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

KALLESTAD QM2/QM300 CONTROL C PACK is the device name listed in this FDA 510(k) record. The listed applicant is Kallestad Diag, A Div. of Erbamont, Inc.. It received FDA 510(k) clearance on 1988-03-25 under 510(k) number K880730. The device is classified under product code DCK. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KALLESTAD QM2/QM300 CONTROL C PACK?

KALLESTAD QM2/QM300 CONTROL C PACK is a medical device that received FDA 510(k) clearance on 1988-03-25. The listed applicant is Kallestad Diag, A Div. of Erbamont, Inc.. The 510(k) number is K880730.

When did KALLESTAD QM2/QM300 CONTROL C PACK receive FDA 510(k) clearance?

KALLESTAD QM2/QM300 CONTROL C PACK received FDA 510(k) clearance on 1988-03-25, under 510(k) number K880730.

Who is the listed applicant for KALLESTAD QM2/QM300 CONTROL C PACK?

The FDA 510(k) record lists Kallestad Diag, A Div. of Erbamont, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KALLESTAD QM2/QM300 CONTROL C PACK?

The FDA product code for KALLESTAD QM2/QM300 CONTROL C PACK is DCK.

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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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