• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Filter, Bacterial, Breathing-Circuit
510(k) Number K884465
Device Name SPIROMETRICS MODEL 2141 SPIRO-FILTER(TM)
Applicant
SPIROMETRICS, INC.
33 OMNI CIRCLE
AUBURN,  ME  04210 -1210
Applicant Contact G CYR
Correspondent
SPIROMETRICS, INC.
33 OMNI CIRCLE
AUBURN,  ME  04210 -1210
Correspondent Contact G CYR
Regulation Number868.5260
Classification Product Code
CAH  
Date Received10/24/1988
Decision Date 11/09/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
-
-