The following data is part of a premarket notification filed by Puritan Bennett Corp. with the FDA for Single Patient Use Nasal (cpap) Circuit.
| Device ID | K890193 |
| 510k Number | K890193 |
| Device Name: | SINGLE PATIENT USE NASAL (CPAP) CIRCUIT |
| Classification | Mask, Oxygen |
| Applicant | PURITAN BENNETT CORP. 9401 INDIAN CREEK PKWY. P.O. BOX 25905 Overland Park, KS 66225 |
| Contact | Marshall Smith |
| Correspondent | Marshall Smith PURITAN BENNETT CORP. 9401 INDIAN CREEK PKWY. P.O. BOX 25905 Overland Park, KS 66225 |
| Product Code | BYG |
| CFR Regulation Number | 868.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-18 |
| Decision Date | 1989-03-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521134782 | K890193 | 000 |
| 10884521127104 | K890193 | 000 |
| 10884521134287 | K890193 | 000 |
| 10884521134355 | K890193 | 000 |
| 10884521134362 | K890193 | 000 |
| 10884521134386 | K890193 | 000 |
| 10884521134409 | K890193 | 000 |
| 10884521134416 | K890193 | 000 |
| 10884521134447 | K890193 | 000 |
| 10884521134461 | K890193 | 000 |
| 10884521134485 | K890193 | 000 |
| 10884521134515 | K890193 | 000 |
| 10884521134522 | K890193 | 000 |
| 10884521127081 | K890193 | 000 |