Skip to content

Sonicator 719 ME 719

by Mettler Electronics Corp.

Sonicator 719 ME 719 is a Class II device made by Mettler Electronics Corp., cleared under FDA 510(k) K112520 on 26 Oct 2011 and listed in FDA GUDID since 15 Sep 2016 (UDI-DI 00816864020272), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K112520

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00816864020272 UDI-DI Date15 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK112520 Date26 Oct 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K112520 decided 26 Oct 2011 Active
  • FDA GUDID UDI-DI 00816864020272 listed 15 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K112520
  2. Listed FDA GUDID 00816864020272

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Sonicator 719
Generic name
Physical therapy ultrasound system
Model / Ref / Catalog
ME 719
Primary DI / UDI-DI
00816864020272
510(k) Number
FDA product code
IMI
GMDN term
Physical therapy ultrasound system
Device class
Class II
Regulation number
890.5300
GUDID distribution status
In Commercial Distribution
Size
Weight — 202 Gram

Similar devices

Other devices filed under FDA product code IMI (Ultrasonic diathermy for use in applying therapeutic deep heat).

Other devices from Mettler Electronics Corp.

See all devices from Mettler Electronics Corp. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)