The following data is part of a premarket notification filed by Caradyne, Ltd. with the FDA for Whisperflow Oxygen Flow Generator - Adjustable Model Wf 8500 Whisperflow Oxygen Flow Generator - Fixed Model Wf 8530 Wh.
| Device ID | K982283 |
| 510k Number | K982283 |
| Device Name: | WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW OXYGEN FLOW GENERATOR - FIXED MODEL WF 8530 WH |
| Classification | Attachment, Breathing, Positive End Expiratory Pressure |
| Applicant | CARADYNE, LTD. 6329 W. WATERVIEW CT. Mccordsville, IN 46055 |
| Contact | Paul E Dryden |
| Correspondent | Paul E Dryden CARADYNE, LTD. 6329 W. WATERVIEW CT. Mccordsville, IN 46055 |
| Product Code | BYE |
| CFR Regulation Number | 868.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-30 |
| Decision Date | 1999-03-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30884838082572 | K982283 | 000 |
| 30884838075505 | K982283 | 000 |
| 30884838075499 | K982283 | 000 |
| 30884838075475 | K982283 | 000 |
| 30884838075468 | K982283 | 000 |
| 30884838075451 | K982283 | 000 |
| 30884838075444 | K982283 | 000 |
| 30884838075437 | K982283 | 000 |
| 30884838075420 | K982283 | 000 |
| 30884838075413 | K982283 | 000 |
| 30884838075406 | K982283 | 000 |
| 30884838075543 | K982283 | 000 |
| 30884838075550 | K982283 | 000 |
| 30884838075567 | K982283 | 000 |
| 30884838082565 | K982283 | 000 |
| 30884838082558 | K982283 | 000 |
| 30884838082541 | K982283 | 000 |
| 30884838082534 | K982283 | 000 |
| 30884838075659 | K982283 | 000 |
| 30884838075642 | K982283 | 000 |
| 30884838075635 | K982283 | 000 |
| 30884838075604 | K982283 | 000 |
| 30884838075598 | K982283 | 000 |
| 30884838075581 | K982283 | 000 |
| 30884838075390 | K982283 | 000 |