FDA 510(k)

PRO-VENT, LINE DRAW, PULSATOR

K-Number: K952516 · 1995-07-14

ApplicantSmiths Industries Medical Systems, Inc.

Decision Date1995-07-14

Product CodeJKA

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

PRO-VENT, LINE DRAW, PULSATOR is the device name listed in this FDA 510(k) record. The listed applicant is Smiths Industries Medical Systems, Inc.. It received FDA 510(k) clearance on 1995-07-14 under 510(k) number K952516. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRO-VENT, LINE DRAW, PULSATOR?

PRO-VENT, LINE DRAW, PULSATOR is a medical device that received FDA 510(k) clearance on 1995-07-14. The listed applicant is Smiths Industries Medical Systems, Inc.. The 510(k) number is K952516.

When did PRO-VENT, LINE DRAW, PULSATOR receive FDA 510(k) clearance?

PRO-VENT, LINE DRAW, PULSATOR received FDA 510(k) clearance on 1995-07-14, under 510(k) number K952516.

Who is the listed applicant for PRO-VENT, LINE DRAW, PULSATOR?

The FDA 510(k) record lists Smiths Industries Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRO-VENT, LINE DRAW, PULSATOR?

The FDA product code for PRO-VENT, LINE DRAW, PULSATOR is JKA.

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Other records listing Smiths Industries Medical Systems, Inc. as applicant

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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.