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Model 9100 PFT/DICO

by Vitalograph Ireland, Ltd. 510(k)

Active United States

510(k) K221030

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK221030 Date15 Jul 2022ClearedStatusActive

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  • Withdrawn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 10 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
BTY
Device Class
Class II
Regulation
21 CFR Part 868.1890
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

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