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M921, Medikro® SpiroStar DX M9470

by Medikro Oy

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06420099000042 UDI-DI Date21 Apr 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
M921, Medikro® SpiroStar DX
Generic Name
Diagnostic spirometer, professional
Model / Reference
M9470
Primary DI / UDI-DI
06420099000042
510(k) Number
FDA Product Code
BZG
GMDN Term
Diagnostic spirometer, professional
Device Class
Class II
Regulation Number
868.1840
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K120577)

Other devices from Medikro Oy

See all devices from Medikro Oy →

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No