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Spirometeo Exhaust

by Timeter Instrument Corp. 510(k)

Active United States

510(k) K770907

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK770907 Date5 Jul 1977ClearedStatusActive

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  • Withdrawn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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