The following data is part of a premarket notification filed by Nova Biomedical Corp. with the FDA for Stat Profile Phox Analyzer.
| Device ID | K014295 |
| 510k Number | K014295 |
| Device Name: | STAT PROFILE PHOX 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 Mac Donald |
| Correspondent | Paul W Mac Donald NOVA BIOMEDICAL CORP. 200 PROSPECT ST. Waltham, MA 02454 -9141 |
| Product Code | CHL |
| Subsequent Product Code | GKR |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JKS |
| Subsequent Product Code | JPI |
| Subsequent Product Code | JPK |
| CFR Regulation Number | 862.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-28 |
| Decision Date | 2002-02-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00385480498470 | K014295 | 000 |
| 00385480227636 | K014295 | 000 |
| 00385480225076 | K014295 | 000 |
| 10385480217955 | K014295 | 000 |
| 00385480215244 | K014295 | 000 |
| 00385480215237 | K014295 | 000 |
| 00385480215220 | K014295 | 000 |
| 00385480215213 | K014295 | 000 |
| 00385480215206 | K014295 | 000 |
| 00385480215190 | K014295 | 000 |
| 00385480215138 | K014295 | 000 |
| 00385480215121 | K014295 | 000 |
| 00385480214971 | K014295 | 000 |
| 10385480214909 | K014295 | 000 |
| 00385480205191 | K014295 | 000 |
| 00385480118026 | K014295 | 000 |
| 00385480065542 | K014295 | 000 |
| 00385480227711 | K014295 | 000 |
| 00385480230230 | K014295 | 000 |
| 00385480498463 | K014295 | 000 |
| 00385480346559 | K014295 | 000 |
| 00385480346474 | K014295 | 000 |
| 00385480250481 | K014295 | 000 |
| 00385480248198 | K014295 | 000 |
| 00385480243278 | K014295 | 000 |
| 10385480239629 | K014295 | 000 |
| 00385480239363 | K014295 | 000 |
| 00385480239356 | K014295 | 000 |
| 00385480239349 | K014295 | 000 |
| 00385480239332 | K014295 | 000 |
| 00385480239325 | K014295 | 000 |
| 00385480239318 | K014295 | 000 |
| 00385480239301 | K014295 | 000 |
| 00385480233972 | K014295 | 000 |
| 00385480231237 | K014295 | 000 |
| 00385480065535 | K014295 | 000 |