The following data is part of a premarket notification filed by Nellcor Puritan Bennett (melville) Ltd. with the FDA for Modification To Suzanne Portable Polysomnograph System.
| Device ID | K030611 |
| 510k Number | K030611 |
| Device Name: | MODIFICATION TO SUZANNE PORTABLE POLYSOMNOGRAPH SYSTEM |
| Classification | Ventilatory Effort Recorder |
| Applicant | NELLCOR PURITAN BENNETT (MELVILLE) LTD. 400-303 TERRY FOX DR. Kanata, Ontario, CA K2k 3j1 |
| Contact | Rob Matheson |
| Correspondent | Rob Matheson NELLCOR PURITAN BENNETT (MELVILLE) LTD. 400-303 TERRY FOX DR. Kanata, Ontario, CA K2k 3j1 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-26 |
| Decision Date | 2003-03-24 |
| Summary: | summary |