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Broomwell Sirona

by Datrix LLC 2 variants

Broomwell Sirona (RX22773-004) is a Class II device made by Datrix LLC, cleared under FDA 510(k) K112601 on 9 Nov 2011 and listed in FDA GUDID since 13 Jul 2017 (UDI-DI 00851074007293), 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) K112601

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 Number00851074007293 UDI-DI Date13 Jul 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK112601 Date9 Nov 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K112601 decided 9 Nov 2011 Active
  • FDA GUDID UDI-DI 00851074007293 listed 13 Jul 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K112601
  2. Listed FDA GUDID 00851074007293

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Broomwell
Generic name
Telemetric electrocardiographic ambulatory recorder
Model / Ref / Catalog
Sirona, RX22773-004
Primary DI / UDI-DI
00851074007293
510(k) Number
FDA product code
MWJ
GMDN term
Telemetric electrocardiographic ambulatory recorder
Device class
Class II
Regulation number
870.2800
GUDID distribution status
In Commercial Distribution

Related devices

Category: Telemetric electrocardiographic ambulatory recorder

Cleared under the same submission (K112601)

and 5 more cleared under K112601

Similar devices

Other devices filed under FDA product code MWJ (Electrocardiograph,Ambulatory(Without Analysis)).

Other devices from Datrix LLC

See all devices from Datrix LLC →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)