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.
Device | LIFESPAN(TM) 100 TCPCO2 MONITOR |
Generic Name | Monitor, Carbon-dioxide, Cutaneous |
Applicant | BIOCHEM INTERNATIONAL, INC. |
Date Received | 1984-12-11 |
Decision Date | 1985-11-19 |
PMA | P820019 |
Supplement | S005 |
Product Code | LKD |
Advisory Committee | Cardiovascular |
Expedited Review | No |
Combination Product | No |
Applicant Address | BIOCHEM INTERNATIONAL, INC. 10238 N. 1650 Rockwood Dr. waukesha, WI 53186 |
Supplement Number | Date | Supplement Type |
---|---|---|
P820019 | Original Filing | |
S007 | 1986-01-17 | |
S006 | 1985-02-15 | |
S005 | 1984-12-11 | |
S004 | ||
S003 | 1984-05-08 | |
S002 | 1983-04-18 | |
S001 |