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Temperature Controller Model 17000

by Healthdyne, Inc. 510(k)

Active United States

510(k) K781530

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK781530 Date14 Nov 1978ClearedStatusActive

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  • Withdrawn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
BZE
Device Class
Class II
Regulation
21 CFR Part 868.5270
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

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