Decision Date1988-11-04
Product CodeDHB
Advisory CommitteeIM
DecisionSubstantially Equivalent
Device Summary
QM300 CONTROL E 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 1988-11-04 under 510(k) number K883537. The device is classified under product code DHB. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the QM300 CONTROL E?
QM300 CONTROL E is a medical device that received FDA 510(k) clearance on 1988-11-04. The listed applicant is Kallestad Diag, A Div. of Erbamont, Inc.. The 510(k) number is K883537.
When did QM300 CONTROL E receive FDA 510(k) clearance?
QM300 CONTROL E received FDA 510(k) clearance on 1988-11-04, under 510(k) number K883537.
Who is the listed applicant for QM300 CONTROL E?
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 QM300 CONTROL E?
The FDA product code for QM300 CONTROL E is DHB.
Related Clinical Trials
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Other records listing Kallestad Diag, A Div. of Erbamont, Inc. as applicant
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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Related Devices (Code: DHB)
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
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