FDA 510(k)

MECHANICAL INFLATION DEVICE

K-Number: K862547 · 1986-09-03

Decision Date1986-09-03

Product CodeDXT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MECHANICAL INFLATION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is American Edwards Laboratories. It received FDA 510(k) clearance on 1986-09-03 under 510(k) number K862547. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MECHANICAL INFLATION DEVICE?

MECHANICAL INFLATION DEVICE is a medical device that received FDA 510(k) clearance on 1986-09-03. The listed applicant is American Edwards Laboratories. The 510(k) number is K862547.

When did MECHANICAL INFLATION DEVICE receive FDA 510(k) clearance?

MECHANICAL INFLATION DEVICE received FDA 510(k) clearance on 1986-09-03, under 510(k) number K862547.

Who is the listed applicant for MECHANICAL INFLATION DEVICE?

The FDA 510(k) record lists American Edwards Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MECHANICAL INFLATION DEVICE?

The FDA product code for MECHANICAL INFLATION DEVICE is DXT.

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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.