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FDA 510(k)

IBM 2991 BLOOD CELL PROCESSOR MOD. 1 & 2

K-Number: K812355 · 1981-09-09

ApplicantIntl. Business Machines
Decision Date1981-09-09
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

IBM 2991 BLOOD CELL PROCESSOR MOD. 1 & 2 is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Business Machines. It received FDA 510(k) clearance on 1981-09-09 under 510(k) number K812355. The device is classified under product code CAC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IBM 2991 BLOOD CELL PROCESSOR MOD. 1 & 2?

IBM 2991 BLOOD CELL PROCESSOR MOD. 1 & 2 is a medical device that received FDA 510(k) clearance on 1981-09-09. The listed applicant is Intl. Business Machines. The 510(k) number is K812355.

When did IBM 2991 BLOOD CELL PROCESSOR MOD. 1 & 2 receive FDA 510(k) clearance?

IBM 2991 BLOOD CELL PROCESSOR MOD. 1 & 2 received FDA 510(k) clearance on 1981-09-09, under 510(k) number K812355.

Who is the listed applicant for IBM 2991 BLOOD CELL PROCESSOR MOD. 1 & 2?

The FDA 510(k) record lists Intl. Business Machines as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IBM 2991 BLOOD CELL PROCESSOR MOD. 1 & 2?

The FDA product code for IBM 2991 BLOOD CELL PROCESSOR MOD. 1 & 2 is CAC.

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Other records listing Intl. Business Machines 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: CAC)

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

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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