The following data is part of a premarket notification filed by Fisher & Paykel Electronics Ltd. with the FDA for Hc500 Servo-controlled Heated Respiratory Humidifier (& Accessories).
| Device ID | K953392 |
| 510k Number | K953392 |
| Device Name: | HC500 SERVO-CONTROLLED HEATED RESPIRATORY HUMIDIFIER (& ACCESSORIES) |
| 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 | Chris Mander |
| Correspondent | Chris Mander 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 | 1995-07-19 |
| Decision Date | 1996-03-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09420012403056 | K953392 | 000 |
| 09420012406316 | K953392 | 000 |
| 09420012406309 | K953392 | 000 |