The following data is part of a premarket notification filed by Cortex Biophysik Gmbh with the FDA for Cortex Metamax.
| Device ID | K001631 |
| 510k Number | K001631 |
| Device Name: | CORTEX METAMAX |
| Classification | Calculator, Pulmonary Function Data |
| Applicant | CORTEX BIOPHYSIK GMBH 962 ALLEGRO LN. Apollo Beach, FL 33572 |
| Contact | Art Ward |
| Correspondent | Art Ward CORTEX BIOPHYSIK GMBH 962 ALLEGRO LN. Apollo Beach, FL 33572 |
| Product Code | BZC |
| CFR Regulation Number | 868.1880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-26 |
| Decision Date | 2001-02-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 74250179232794 | K001631 | 000 |