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FDA 510(k)

3038 OPTION B-COMPUT. TRANS. TERMINAL

K-Number: K761318 · 1977-01-06

ApplicantCambridge Instruments, Inc.
Decision Date1977-01-06
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

3038 OPTION B-COMPUT. TRANS. TERMINAL is the device name listed in this FDA 510(k) record. The listed applicant is Cambridge Instruments, Inc.. It received FDA 510(k) clearance on 1977-01-06 under 510(k) number K761318. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3038 OPTION B-COMPUT. TRANS. TERMINAL?

3038 OPTION B-COMPUT. TRANS. TERMINAL is a medical device that received FDA 510(k) clearance on 1977-01-06. The listed applicant is Cambridge Instruments, Inc.. The 510(k) number is K761318.

When did 3038 OPTION B-COMPUT. TRANS. TERMINAL receive FDA 510(k) clearance?

3038 OPTION B-COMPUT. TRANS. TERMINAL received FDA 510(k) clearance on 1977-01-06, under 510(k) number K761318.

Who is the listed applicant for 3038 OPTION B-COMPUT. TRANS. TERMINAL?

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

What is the FDA product code for 3038 OPTION B-COMPUT. TRANS. TERMINAL?

The FDA product code for 3038 OPTION B-COMPUT. TRANS. TERMINAL is DXH. This falls under the Hematology category.

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Other records listing Cambridge Instruments, Inc. 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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