TESLACON(TM) NMR IMAGING SYSTEM

FDA Premarket Approval P830051 S012

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

DeviceTESLACON(TM) NMR IMAGING SYSTEM
Generic NameSystem, Nuclear Magnetic Resonance Imaging
ApplicantTECHNICARE CORP.
Date Received1986-08-18
Decision Date1986-11-05
PMAP830051
SupplementS012
Product CodeLNH 
Advisory CommitteeRadiology
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address TECHNICARE CORP. po Box 5130 cleveland, OH 44101

Supplemental Filings

Supplement NumberDateSupplement Type
P830051Original Filing
S015 1988-02-17 Normal 180 Day Track
S014 1987-03-30 Normal 180 Day Track
S013 1986-09-04 Normal 180 Day Track
S012 1986-08-18 Normal 180 Day Track
S011 1986-05-29 Normal 180 Day Track
S010 1986-04-10
S009 1986-04-10
S008 1986-03-06
S007 1986-02-05
S006 1985-10-08
S005 1985-08-16
S004 1985-05-07
S003 1985-04-30
S002 1985-03-06
S001 1984-05-23

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.