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 | CUTANIOUS GAS MONITOR |
Generic Name | Monitor, Carbon-dioxide, Cutaneous |
Applicant | SENSORMEDICS CORP. |
Date Received | 1984-10-23 |
Decision Date | 1985-01-11 |
PMA | P830008 |
Supplement | S002 |
Product Code | LKD |
Advisory Committee | Cardiovascular |
Expedited Review | No |
Combination Product | No |
Applicant Address | SENSORMEDICS CORP. 1630 S. State College Blvd. anaheim, CA 92806 |
Supplement Number | Date | Supplement Type |
---|---|---|
P830008 | Original Filing | |
S003 | 1984-11-06 | |
S002 | 1984-10-23 | |
S001 | 1984-02-16 |