The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Gem Premier 5000 (measured Parameters: Ph, Pco2 And Po2).
| Device ID | K160412 |
| 510k Number | K160412 |
| Device Name: | GEM Premier 5000 (Measured Parameters: PH, PCO2 And PO2) |
| Classification | Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
| Applicant | Instrumentation Laboratory Co. 180 Hartwell Road Bedford, MA 01730 |
| Contact | Carol Marble |
| Correspondent | Carol Marble Instrumentation Laboratory Co. 180 Hartwell Road Bedford, MA 01730 |
| Product Code | CHL |
| CFR Regulation Number | 862.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-12 |
| Decision Date | 2016-12-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08426950869634 | K160412 | 000 |
| 08426951027316 | K160412 | 000 |
| 08426951027309 | K160412 | 000 |
| 08426951027293 | K160412 | 000 |
| 08426951027286 | K160412 | 000 |
| 08426951027279 | K160412 | 000 |
| 08426951027262 | K160412 | 000 |
| 08426951027255 | K160412 | 000 |
| 08426951027248 | K160412 | 000 |
| 08426951027231 | K160412 | 000 |
| 08426951027224 | K160412 | 000 |
| 08426951027217 | K160412 | 000 |
| 08426951027200 | K160412 | 000 |
| 08426951027194 | K160412 | 000 |
| 08426951027187 | K160412 | 000 |
| 08426951027323 | K160412 | 000 |
| 08426951027330 | K160412 | 000 |
| 08426951027477 | K160412 | 000 |
| 08426951027460 | K160412 | 000 |
| 08426951027453 | K160412 | 000 |
| 08426951027446 | K160412 | 000 |
| 08426951027439 | K160412 | 000 |
| 08426951027422 | K160412 | 000 |
| 08426951027415 | K160412 | 000 |
| 08426951027408 | K160412 | 000 |
| 08426951027392 | K160412 | 000 |
| 08426951027385 | K160412 | 000 |
| 08426951027378 | K160412 | 000 |
| 08426951027361 | K160412 | 000 |
| 08426951027354 | K160412 | 000 |
| 08426951027347 | K160412 | 000 |
| 08426950870227 | K160412 | 000 |