The following data is part of a premarket notification filed by Medical Developments International with the FDA for Space Chamber Plus Compact Space Chamber Plus.
| Device ID | K122252 |
| 510k Number | K122252 |
| Device Name: | SPACE CHAMBER PLUS COMPACT SPACE CHAMBER PLUS |
| Classification | Holding Chambers, Direct Patient Interface |
| Applicant | MEDICAL DEVELOPMENTS INTERNATIONAL SUITE 408, 460 PACIFIC HIGHWAY St Leonards, AU 2065 |
| Contact | Tracey Bullivant |
| Correspondent | Tracey Bullivant MEDICAL DEVELOPMENTS INTERNATIONAL SUITE 408, 460 PACIFIC HIGHWAY St Leonards, AU 2065 |
| Product Code | NVP |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-27 |
| Decision Date | 2013-11-13 |
| Summary: | summary |