FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
O2 CARE
K Number: K882461
·
Decision Nov 28, 1988
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
22
Applicant Total
26
Review Days
166
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Basic Information
- Device Name
- O2 CARE
- K Number
- K882461
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5650
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Ballard Medical Products
- Date Received
- June 15, 1988
- Decision Date
- November 28, 1988
- Product Code
- KPJ
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KPJ | Chamber, Oxygen, Topical, Extremity | FDA class 2 | General, Plastic Surgery |
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|---|---|---|---|
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| K000495 | BALLARD MEDICAL PRODUCTS EPIDURAL AND SPINAL NEEDLES | Mar 28, 2000 | Substantially Equivalent |
| K993138 | BALLARD MIC-KEY G LOW PROFILE GASTROSTOMY REPLACEMENT KIT | Oct 20, 1999 | Substantially Equivalent |
| K990376 | BALLARD MEDICAL PRODUCTS FACILETOME BOW STRING PAPILLOTOME | May 3, 1999 | Substantially Equivalent |
| K982894 | MIC-KEY GLOW PROFILE GASTROSTOMY REPLACEMENT KIT | Sep 11, 1998 | Substantially Equivalent |
| K974630 | 72 HOUR USE TRACH CARE WITH MICROBAN | Mar 11, 1998 | Substantially Equivalent |
| K964369 | TRACH CARE SET WITH MICROBAN | Feb 11, 1997 | Substantially Equivalent |
| K951533 | EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KIT | Jul 5, 1995 | Substantially Equivalent |