FDA 510(k)
Substantially Equivalent
🇺🇸 United States
BABY LIGHT METER
K Number: K837494
·
Decision Jun 14, 1983
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
9
Review Days
56
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Basic Information
- Device Name
- BABY LIGHT METER
- K Number
- K837494
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Rocky Mountain Medical Corp.
- Date Received
- April 19, 1983
- Decision Date
- June 14, 1983
- Advisory Committee
- Unknown
- Review Advisory Committee
- RA
- Third Party
- N
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 |
| K834430 | OMNI INFANT PHOTOTHERAPY UNIT | Apr 30, 1984 | Substantially Equivalent |
| K832298 | BABY LIGHT DOSIMETER | Oct 19, 1983 | Substantially Equivalent |