The following data is part of a premarket notification filed by Ballard Medical Products with the FDA for O2 Care.
| Device ID | K882461 |
| 510k Number | K882461 |
| Device Name: | O2 CARE |
| Classification | Chamber, Oxygen, Topical, Extremity |
| Applicant | BALLARD MEDICAL PRODUCTS 6864 SOUTH 300 WEST Midvale, UT 84047 |
| Contact | Ernest Chamberlain |
| Correspondent | Ernest Chamberlain BALLARD MEDICAL PRODUCTS 6864 SOUTH 300 WEST Midvale, UT 84047 |
| Product Code | KPJ |
| CFR Regulation Number | 878.5650 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-15 |
| Decision Date | 1988-11-28 |