The following data is part of a premarket notification filed by Bayer Healthcare, Llc with the FDA for Bayer Rapidlab 1200 System.
| Device ID | K031560 |
| 510k Number | K031560 |
| Device Name: | BAYER RAPIDLAB 1200 SYSTEM |
| Classification | Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
| Applicant | BAYER HEALTHCARE, LLC 63 NORTH ST. Medfield, MA 02052 -1688 |
| Contact | Mary E Gray |
| Correspondent | Mary E Gray BAYER HEALTHCARE, LLC 63 NORTH ST. Medfield, MA 02052 -1688 |
| Product Code | CHL |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGA |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | GKR |
| Subsequent Product Code | JFP |
| Subsequent Product Code | JGS |
| Subsequent Product Code | KHP |
| CFR Regulation Number | 862.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-19 |
| Decision Date | 2003-12-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414570501 | K031560 | 000 |
| 00630414492605 | K031560 | 000 |
| 00630414492612 | K031560 | 000 |
| 00630414492629 | K031560 | 000 |
| 00630414492636 | K031560 | 000 |
| 00630414492643 | K031560 | 000 |
| 00630414492650 | K031560 | 000 |
| 00630414492667 | K031560 | 000 |
| 00630414510293 | K031560 | 000 |
| 00630414515540 | K031560 | 000 |
| 00630414515557 | K031560 | 000 |
| 00630414515564 | K031560 | 000 |
| 00630414515571 | K031560 | 000 |
| 00630414570457 | K031560 | 000 |
| 00630414570464 | K031560 | 000 |
| 00630414570471 | K031560 | 000 |
| 00630414570488 | K031560 | 000 |
| 00630414570495 | K031560 | 000 |
| 00630414132051 | K031560 | 000 |