FDA 510(k)

BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXX

K-Number: K981747 · 1998-08-20

Decision Date1998-08-20

Product CodeDRS

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXX is the device name listed in this FDA 510(k) record. The listed applicant is Sunscope Intl., Inc.. It received FDA 510(k) clearance on 1998-08-20 under 510(k) number K981747. The device is classified under product code DRS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXX?

BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXX is a medical device that received FDA 510(k) clearance on 1998-08-20. The listed applicant is Sunscope Intl., Inc.. The 510(k) number is K981747.

When did BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXX receive FDA 510(k) clearance?

BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXX received FDA 510(k) clearance on 1998-08-20, under 510(k) number K981747.

Who is the listed applicant for BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXX?

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

What is the FDA product code for BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXX?

The FDA product code for BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXX is DRS.

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Other records listing Sunscope Intl., Inc. as applicant

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.