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FDA 510(k)

ABN ANEROID SPHYGMOMANOMETER

K-Number: K012444 · 2001-08-16

ApplicantPt. Sugih Instrumendo Abadi
Decision Date2001-08-16
Product CodeDXQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ABN ANEROID SPHYGMOMANOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Pt. Sugih Instrumendo Abadi. It received FDA 510(k) clearance on 2001-08-16 under 510(k) number K012444. The device is classified under product code DXQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABN ANEROID SPHYGMOMANOMETER?

ABN ANEROID SPHYGMOMANOMETER is a medical device that received FDA 510(k) clearance on 2001-08-16. The listed applicant is Pt. Sugih Instrumendo Abadi. The 510(k) number is K012444.

When did ABN ANEROID SPHYGMOMANOMETER receive FDA 510(k) clearance?

ABN ANEROID SPHYGMOMANOMETER received FDA 510(k) clearance on 2001-08-16, under 510(k) number K012444.

Who is the listed applicant for ABN ANEROID SPHYGMOMANOMETER?

The FDA 510(k) record lists Pt. Sugih Instrumendo Abadi as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ABN ANEROID SPHYGMOMANOMETER?

The FDA product code for ABN ANEROID SPHYGMOMANOMETER is DXQ.

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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.

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