The following data is part of a premarket notification filed by Fisher & Paykel Electronics Ltd. with the FDA for Models Mr700/mr720/mr730 Dual Servo Resp Humid Acc.
| Device ID | K913368 |
| 510k Number | K913368 |
| Device Name: | MODELS MR700/MR720/MR730 DUAL SERVO RESP HUMID ACC |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | FISHER & PAYKEL ELECTRONICS LTD. 25 CARBINE ROAD PANMURE P.O. BOX 14 348 PANMURE Auckland, New Zealand, NZ |
| Contact | Richard Belgrave |
| Correspondent | Richard Belgrave FISHER & PAYKEL ELECTRONICS LTD. 25 CARBINE ROAD PANMURE P.O. BOX 14 348 PANMURE Auckland, New Zealand, NZ |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-24 |
| Decision Date | 1992-01-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09420012403148 | K913368 | 000 |
| 09420012401526 | K913368 | 000 |
| 09420012401502 | K913368 | 000 |
| 09420012401618 | K913368 | 000 |
| 09420012401588 | K913368 | 000 |
| 09420012401533 | K913368 | 000 |
| 09420012401519 | K913368 | 000 |
| 09420012401496 | K913368 | 000 |
| 09420012401489 | K913368 | 000 |
| 09420012401113 | K913368 | 000 |
| 09420012401120 | K913368 | 000 |
| 09420012401144 | K913368 | 000 |
| 09420012403131 | K913368 | 000 |
| 09420012403117 | K913368 | 000 |
| 09420012403063 | K913368 | 000 |
| 09420012403001 | K913368 | 000 |
| 09420012402998 | K913368 | 000 |
| 09420012401199 | K913368 | 000 |
| 09420012401182 | K913368 | 000 |
| 09420012401168 | K913368 | 000 |
| 09420012401601 | K913368 | 000 |