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 Densitometer, Bone
510(k) Number K864299
Device Name NOVO BMC-LAB 23, BONE DENSITOMETER
Applicant
Scan Detectronic Laboratories, Inc.
512 Danbury Rd.
P.O. Box D
New Milford,  CT  06776
Applicant Contact ADEL HOLL
Correspondent
Scan Detectronic Laboratories, Inc.
512 Danbury Rd.
P.O. Box D
New Milford,  CT  06776
Correspondent Contact ADEL HOLL
Regulation Number892.1170
Classification Product Code
KGI  
Date Received10/31/1986
Decision Date 11/12/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-