The following data is part of a premarket notification filed by Caire, Inc. with the FDA for Modification To: Spirit.
| Device ID | K080023 |
| 510k Number | K080023 |
| Device Name: | MODIFICATION TO: SPIRIT |
| Classification | Unit, Liquid-oxygen, Portable |
| Applicant | CAIRE, INC. 1800 SANDY PLAINS INDUSTRIAL PARKWAY, STE.316 Marietta, GA 30066 |
| Contact | Zulfiqar A Choudary |
| Correspondent | Zulfiqar A Choudary CAIRE, INC. 1800 SANDY PLAINS INDUSTRIAL PARKWAY, STE.316 Marietta, GA 30066 |
| Product Code | BYJ |
| CFR Regulation Number | 868.5655 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-04 |
| Decision Date | 2008-06-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M766139465080 | K080023 | 000 |
| M766117697470 | K080023 | 000 |
| M766118114660 | K080023 | 000 |
| M766119402330 | K080023 | 000 |
| M766119405320 | K080023 | 000 |
| M766130429710 | K080023 | 000 |
| M766130429800 | K080023 | 000 |
| M766130705690 | K080023 | 000 |
| M766130911750 | K080023 | 000 |
| M766131001070 | K080023 | 000 |
| M766131031300 | K080023 | 000 |
| M766131041670 | K080023 | 000 |
| M766131042040 | K080023 | 000 |
| M766138327460 | K080023 | 000 |
| M766138460130 | K080023 | 000 |
| M766138460210 | K080023 | 000 |
| M766117514830 | K080023 | 000 |