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FDA 510(k)

BP-408 MARK II

K-Number: K884885 · 1989-02-23

ApplicantColin Medical Instruments Corp.
Decision Date1989-02-23
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BP-408 MARK II 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 1989-02-23 under 510(k) number K884885. 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 BP-408 MARK II?

BP-408 MARK II is a medical device that received FDA 510(k) clearance on 1989-02-23. The listed applicant is Colin Medical Instruments Corp.. The 510(k) number is K884885.

When did BP-408 MARK II receive FDA 510(k) clearance?

BP-408 MARK II received FDA 510(k) clearance on 1989-02-23, under 510(k) number K884885.

Who is the listed applicant for BP-408 MARK II?

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 BP-408 MARK II?

The FDA product code for BP-408 MARK II is DXN.

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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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