The following data is part of a premarket notification filed by Nova Biomedical Corporation with the FDA for Stat Profile Prime Ccs Analyzer System, Stat Profile Prime Auto Qc Cartridge Ccs, Stat Profile Prime Ampuled Control Abg/ccs, Stat Profile Prime Calibrtor Cartridge Ccs/ccs Comp, Nova Linearity Standard Set A.
| Device ID | K141907 |
| 510k Number | K141907 |
| Device Name: | STAT PROFILE PRIME CCS ANALYZER SYSTEM, STAT PROFILE PRIME AUTO QC CARTRIDGE CCS, STAT PROFILE PRIME AMPULED CONTROL ABG/CCS, STAT PROFILE PRIME CALIBRTOR CARTRIDGE CCS/CCS COMP, NOVA LINEARITY STANDARD SET A |
| Classification | Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
| Applicant | NOVA BIOMEDICAL CORPORATION 200 Prospect St Waltham, MA 02454 |
| Contact | Paul W Macdonald |
| Correspondent | Paul W Macdonald NOVA BIOMEDICAL CORPORATION 200 Prospect St Waltham, MA 02454 |
| Product Code | CHL |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGA |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | GKF |
| Subsequent Product Code | JFP |
| Subsequent Product Code | JGS |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJS |
| Subsequent Product Code | KHP |
| CFR Regulation Number | 862.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-15 |
| Decision Date | 2015-05-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10385480552643 | K141907 | 000 |
| 00385480528627 | K141907 | 000 |
| 00385480528610 | K141907 | 000 |
| 00385480528573 | K141907 | 000 |
| 00385480528566 | K141907 | 000 |
| 00385480526692 | K141907 | 000 |
| 00385480526166 | K141907 | 000 |
| 00385480525824 | K141907 | 000 |
| 00385480524841 | K141907 | 000 |
| 00385480524278 | K141907 | 000 |
| 00385480451505 | K141907 | 000 |
| 00385480420433 | K141907 | 000 |
| 10385480420331 | K141907 | 000 |
| 10385480420324 | K141907 | 000 |
| 10385480353493 | K141907 | 000 |
| 00385480252171 | K141907 | 000 |
| 00385480140713 | K141907 | 000 |
| 00385480528634 | K141907 | 000 |
| 00385480528641 | K141907 | 000 |
| 00385480528658 | K141907 | 000 |
| 10385480552636 | K141907 | 000 |
| 00385480536677 | K141907 | 000 |
| 00385480536660 | K141907 | 000 |
| 00385480536653 | K141907 | 000 |
| 00385480536578 | K141907 | 000 |
| 00385480536561 | K141907 | 000 |
| 10385480534694 | K141907 | 000 |
| 00385480534673 | K141907 | 000 |
| 00385480534666 | K141907 | 000 |
| 00385480534550 | K141907 | 000 |
| 00385480534215 | K141907 | 000 |
| 00385480534208 | K141907 | 000 |
| 00385480534185 | K141907 | 000 |
| 00385480533652 | K141907 | 000 |
| 00385480533645 | K141907 | 000 |
| 00385480531054 | K141907 | 000 |
| 10385480642511 | K141907 | 000 |