The following data is part of a premarket notification filed by Puritan Bennett Corp. with the FDA for Knightstar 335.
| Device ID | K973004 |
| 510k Number | K973004 |
| Device Name: | KNIGHTSTAR 335 |
| Classification | Ventilator, Continuous, Minimal Ventilatory Support, Facility Use |
| Applicant | PURITAN BENNETT CORP. 9728 PFLUMM RD. P.O.BOX 15915 Lenexa, KS 66215 -5915 |
| Contact | C. Marshall Smith |
| Correspondent | C. Marshall Smith PURITAN BENNETT CORP. 9728 PFLUMM RD. P.O.BOX 15915 Lenexa, KS 66215 -5915 |
| Product Code | MNT |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-13 |
| Decision Date | 1998-07-16 |
| Summary: | summary |