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 | TCPCO2 MONITORING SYSTEM |
Generic Name | Monitor, Carbon-dioxide, Cutaneous |
Applicant | NARCO SCIENTIFIC |
Date Received | 1984-01-11 |
Decision Date | 1984-04-18 |
PMA | P820025 |
Supplement | S001 |
Product Code | LKD |
Advisory Committee | Cardiovascular |
Expedited Review | No |
Combination Product | No |
Applicant Address | NARCO SCIENTIFIC 330 Jacksonville Rd. hatboro, PA 19040 |
Supplement Number | Date | Supplement Type |
---|---|---|
P820025 | Original Filing | |
S001 | 1984-01-11 |