The following data is part of a premarket notification filed by Healthdyne Technologies, Inc. with the FDA for Twister Oxygen Concentrator Model 600, Twister Oxygen Concentrator W/opi Model 605.
| Device ID | K972614 |
| 510k Number | K972614 |
| Device Name: | TWISTER OXYGEN CONCENTRATOR MODEL 600, TWISTER OXYGEN CONCENTRATOR W/OPI MODEL 605 |
| Classification | Generator, Oxygen, Portable |
| Applicant | HEALTHDYNE TECHNOLOGIES, INC. 1255 KENNESTONE CIR. Marietta, GA 30066 |
| Contact | Betsy Cortelloni |
| Correspondent | Betsy Cortelloni HEALTHDYNE TECHNOLOGIES, INC. 1255 KENNESTONE CIR. Marietta, GA 30066 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-14 |
| Decision Date | 1998-01-20 |