The following data is part of a premarket notification filed by In-line Diagnostics Corp. with the FDA for Crit-line Monitor (clmiii).
| Device ID | K972470 |
| 510k Number | K972470 |
| Device Name: | CRIT-LINE MONITOR (CLMIII) |
| Classification | System, Hemodialysis, Access Recirculation Monitoring |
| Applicant | IN-LINE DIAGNOSTICS CORP. 55 NORTHERN BLVD. Great Neck, NY 11021 |
| Contact | Thomas J Bouchard |
| Correspondent | Thomas J Bouchard IN-LINE DIAGNOSTICS CORP. 55 NORTHERN BLVD. Great Neck, NY 11021 |
| Product Code | MQS |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-01 |
| Decision Date | 1997-12-11 |
| Summary: | summary |