FDA 510(k) Application Details - K991412

Device Classification Name Meter, Peak Flow, Spirometry

  More FDA Info for this Device
510(K) Number K991412
Device Name Meter, Peak Flow, Spirometry
Applicant VITALOGRAPH, INC.
8347 QUIVIRA RD.
LENEXA, KS 66215 US
Other 510(k) Applications for this Company
Contact PHIL HEMES
Other 510(k) Applications for this Contact
Regulation Number 868.1860

  More FDA Info for this Regulation Number
Classification Product Code BZH
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 04/23/1999
Decision Date 02/04/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact