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Braemar Model DL700 Ambulatory Electrocardiographic Recorder

by Braemar Corp. 510(k)

Active United States

510(k) K945130

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK945130 Date12 Apr 1995ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DSH
Device Class
Class II
Regulation
21 CFR Part 870.2800
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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