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Ultrascope

by L&M Ultrascope Life Monitoring Sys.

510(k) K780200

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK780200 Date2 Mar 1978ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JAF
Device Class
Class II
Regulation
21 CFR Part 892.1540
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Ultrascope is a nonfetal ultrasonic monitor used in radiology. It is a Class II ultrasound system designed for monitoring purposes.

The device received FDA 510(k) clearance under K-number K780200 on March 2, 1978, and is substantially equivalent to a predicate device. It is manufactured by L&M Ultrascope Life Monitoring Sys. and falls under product code JAF and regulation number 892.1540.

Other devices from L&M Ultrascope Life Monitoring Sys.

Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Ultrascope used for?

    The Ultrascope is a nonfetal ultrasonic monitor designed for monitoring purposes in radiology, as indicated by its FDA 510(k) clearance and product code JAF under regulation 892.1540.

  • How was the Ultrascope cleared for market?

    The Ultrascope received FDA 510(k) clearance via the traditional pathway on March 2, 1978, under K-number K780200, based on a determination of substantial equivalence to a predicate device.

  • What regulatory classification does the Ultrascope have?

    The Ultrascope is classified as a Class II medical device, as confirmed by its FDA 510(k) clearance and the openfda field specifying device_class=2.