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FDA 510(k)

BP8800T/8000IR/8300G NON-INVASIVE BLOOD PRES. SYST

K-Number: K921048 · 1993-07-01

ApplicantColin Medical Instruments Corp.
Decision Date1993-07-01
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BP8800T/8000IR/8300G NON-INVASIVE BLOOD PRES. SYST is the device name listed in this FDA 510(k) record. The listed applicant is Colin Medical Instruments Corp.. It received FDA 510(k) clearance on 1993-07-01 under 510(k) number K921048. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BP8800T/8000IR/8300G NON-INVASIVE BLOOD PRES. SYST?

BP8800T/8000IR/8300G NON-INVASIVE BLOOD PRES. SYST is a medical device that received FDA 510(k) clearance on 1993-07-01. The listed applicant is Colin Medical Instruments Corp.. The 510(k) number is K921048.

When did BP8800T/8000IR/8300G NON-INVASIVE BLOOD PRES. SYST receive FDA 510(k) clearance?

BP8800T/8000IR/8300G NON-INVASIVE BLOOD PRES. SYST received FDA 510(k) clearance on 1993-07-01, under 510(k) number K921048.

Who is the listed applicant for BP8800T/8000IR/8300G NON-INVASIVE BLOOD PRES. SYST?

The FDA 510(k) record lists Colin Medical Instruments Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BP8800T/8000IR/8300G NON-INVASIVE BLOOD PRES. SYST?

The FDA product code for BP8800T/8000IR/8300G NON-INVASIVE BLOOD PRES. SYST is DXN.

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Other records listing Colin Medical Instruments Corp. as applicant

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Related Devices (Code: DXN)

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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