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Respicentral(Tm)

by Dickstein, Shapiro & Morin 510(k)

Active United States

510(k) K863538

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK863538 Date24 Sep 1986ClearedStatusActive

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  • Withdrawn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
BZK
Device Class
Class II
Regulation
21 CFR Part 868.1850
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

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