FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OMNI INFANT PHOTOTHERAPY UNIT
K Number: K834430
·
Decision Apr 30, 1984
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
70
Applicant Total
9
Review Days
136
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Basic Information
- Device Name
- OMNI INFANT PHOTOTHERAPY UNIT
- K Number
- K834430
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5700
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Rocky Mountain Medical Corp.
- Date Received
- December 16, 1983
- Decision Date
- April 30, 1984
- Product Code
- LBI
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| LBI | Unit, Neonatal Phototherapy | FDA class 2 | General Hospital |
Similar 510(k) Clearances
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Other Clearances by Rocky Mountain Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K890202 | TELE-TEMP THERMOMETER | Apr 5, 1989 | Substantially Equivalent |
| K860120 | NURSERY AMBIENT LIGHT METER | Feb 19, 1986 | Substantially Equivalent |
| K852167 | ISOVOL-EXCHANGE TRAY | Nov 18, 1985 | Substantially Equivalent |
| K853970 | ALPHA CHUCK | Nov 8, 1985 | Substantially Equivalent |
| K853790 | BABE SHADE-INFANT AMBIENT LIGHT INTENSITY REDUCER | Oct 4, 1985 | Substantially Equivalent |
| K851876 | PREFER INCONTINENCE AID | Jun 12, 1985 | Substantially Equivalent |
| K832298 | BABY LIGHT DOSIMETER | Oct 19, 1983 | Substantially Equivalent |
| K837494 | BABY LIGHT METER | Jun 14, 1983 | Substantially Equivalent |