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FDA 510(k)

FLUID REMOVAL ASSEMBLY

K-Number: K840490 · 1984-04-17

ApplicantAckrad Laboratories
Decision Date1984-04-17
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

FLUID REMOVAL ASSEMBLY is the device name listed in this FDA 510(k) record. The listed applicant is Ackrad Laboratories. It received FDA 510(k) clearance on 1984-04-17 under 510(k) number K840490. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLUID REMOVAL ASSEMBLY?

FLUID REMOVAL ASSEMBLY is a medical device that received FDA 510(k) clearance on 1984-04-17. The listed applicant is Ackrad Laboratories. The 510(k) number is K840490.

When did FLUID REMOVAL ASSEMBLY receive FDA 510(k) clearance?

FLUID REMOVAL ASSEMBLY received FDA 510(k) clearance on 1984-04-17, under 510(k) number K840490.

Who is the listed applicant for FLUID REMOVAL ASSEMBLY?

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

What is the FDA product code for FLUID REMOVAL ASSEMBLY?

The FDA product code for FLUID REMOVAL ASSEMBLY is FMF.

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Other records listing Ackrad Laboratories as applicant

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.

K021272SIB CATHETER, MODEL 61-7005K020954H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE TRAY & MULTIPURPOSE PROCEDURE TRAYK020951H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007K970492INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETERK961752H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607)K940176ACKRAD IUI SET FOR INTRAUTERINE INSEMINATION

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Related Devices (Code: FMF)

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

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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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