The following data is part of a premarket notification filed by Nova Biomedical Corp. with the FDA for Modification To Stat Profile Phox Plus Analyzer.
| Device ID | K002613 |
| 510k Number | K002613 |
| Device Name: | MODIFICATION TO STAT PROFILE PHOX PLUS ANALYZER |
| Classification | Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
| Applicant | NOVA BIOMEDICAL CORP. 200 PROSPECT ST. Waltham, MA 02454 -9141 |
| Contact | Paul W Macdonald |
| Correspondent | Paul W Macdonald NOVA BIOMEDICAL CORP. 200 PROSPECT ST. Waltham, MA 02454 -9141 |
| Product Code | CHL |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGA |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | GJS |
| Subsequent Product Code | GKR |
| Subsequent Product Code | JFP |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JPI |
| CFR Regulation Number | 862.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-22 |
| Decision Date | 2000-10-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00385480498487 | K002613 | 000 |
| 10385480278123 | K002613 | 000 |
| 00385480278119 | K002613 | 000 |
| 00385480278102 | K002613 | 000 |
| 00385480278096 | K002613 | 000 |
| 00385480278072 | K002613 | 000 |
| 10385480278031 | K002613 | 000 |
| 00385480276139 | K002613 | 000 |
| 00385480276122 | K002613 | 000 |
| 00385480276115 | K002613 | 000 |
| 00385480278133 | K002613 | 000 |
| 00385480278966 | K002613 | 000 |
| 00385480289535 | K002613 | 000 |
| 00385480346436 | K002613 | 000 |
| 00385480329651 | K002613 | 000 |
| 10385480322048 | K002613 | 000 |
| 00385480306461 | K002613 | 000 |
| 00385480306454 | K002613 | 000 |
| 00385480306447 | K002613 | 000 |
| 00385480306430 | K002613 | 000 |
| 00385480289696 | K002613 | 000 |
| 00385480289542 | K002613 | 000 |
| 00385480276108 | K002613 | 000 |