FDA 510(k)

ULTRAFILTRATION SCALE

K-Number: K781633 · 1978-12-07

ApplicantExtracorporeal Medical Specialities, Inc.

Decision Date1978-12-07

Product CodeFIL

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

ULTRAFILTRATION SCALE is the device name listed in this FDA 510(k) record. The listed applicant is Extracorporeal Medical Specialities, Inc.. It received FDA 510(k) clearance on 1978-12-07 under 510(k) number K781633. The device is classified under product code FIL. It was reviewed by the GU advisory panel. Product code FIL falls under the category of Radiology, which covers imaging devices and accessories used in diagnostic radiology. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRAFILTRATION SCALE?

ULTRAFILTRATION SCALE is a medical device that received FDA 510(k) clearance on 1978-12-07. The listed applicant is Extracorporeal Medical Specialities, Inc.. The 510(k) number is K781633.

When did ULTRAFILTRATION SCALE receive FDA 510(k) clearance?

ULTRAFILTRATION SCALE received FDA 510(k) clearance on 1978-12-07, under 510(k) number K781633.

Who is the listed applicant for ULTRAFILTRATION SCALE?

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

What is the FDA product code for ULTRAFILTRATION SCALE?

The FDA product code for ULTRAFILTRATION SCALE is FIL. This falls under the Radiology category.

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Other records listing Extracorporeal Medical Specialities, Inc. as applicant

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Related Devices (Code: FIL)

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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.