FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BABE SHADE-INFANT AMBIENT LIGHT INTENSITY REDUCER
K Number: K853790
·
Decision Oct 4, 1985
Classifications
1
FEI Numbers
1390
Registration Numbers
1390
Same Product Code
645
Applicant Total
9
Review Days
24
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- BABE SHADE-INFANT AMBIENT LIGHT INTENSITY REDUCER
- K Number
- K853790
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.5850
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Rocky Mountain Medical Corp.
- Date Received
- September 10, 1985
- Decision Date
- October 4, 1985
- Product Code
- HQY
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| HQY | Sunglasses (Non-Prescription Including Photosensitive) | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HQY), ordered by most recent decision date.
NON-PRESCRIPTION SUNGLASSES
FDA 510(k)
FDA Class 1
·Ophthalmic
NON-PRESCRIPTION SUNGLASSES
FDA 510(k)
FDA Class 1
·Ophthalmic
NON-PRESCRIPTION SUNGLASSES
FDA 510(k)
FDA Class 1
·Ophthalmic
SUNGLASSES
FDA 510(k)
FDA Class 1
·Ophthalmic
SUNGLASSES
FDA 510(k)
FDA Class 1
·Ophthalmic
MULTI
FDA 510(k)
FDA Class 1
·Ophthalmic
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 |
| 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 |
| K837494 | BABY LIGHT METER | Jun 14, 1983 | Substantially Equivalent |