Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 spirometer, diagnostic
510(k) Number K862023
Device Name SPIROMATE AS-600
Applicant
RIKO MEDICAL & SCIENTIFIC INSTRUMENT CORP.
3000 MARCUS AVE.
LAKE SUCCESS,  NY  11042
Applicant Contact NORMAN KANESAKA
Correspondent
RIKO MEDICAL & SCIENTIFIC INSTRUMENT CORP.
3000 MARCUS AVE.
LAKE SUCCESS,  NY  11042
Correspondent Contact NORMAN KANESAKA
Regulation Number868.1840
Classification Product Code
BZG  
Date Received05/28/1986
Decision Date 06/17/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-