The following data is part of a premarket notification filed by Kal-med Llc with the FDA for Pylant Monitor.
| Device ID | K191858 |
| 510k Number | K191858 |
| Device Name: | Pylant Monitor |
| Classification | Cuff, Tracheal Tube, Inflatable |
| Applicant | Kal-Med LLC 570 Percival Avenue Kensington, CT 06037 |
| Contact | Sandra Greenwood |
| Correspondent | Sandra Greenwood Kal-Med LLC 570 Percival Avenue Kensington, CT 06037 |
| Product Code | BSK |
| CFR Regulation Number | 868.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-11 |
| Decision Date | 2020-02-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860010850909 | K191858 | 000 |