FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LOCATOR, FOREIGN BODY
K Number: K781892
·
Decision Dec 4, 1978
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
3
Applicant Total
5
Review Days
26
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Basic Information
- Device Name
- LOCATOR, FOREIGN BODY
- K Number
- K781892
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4400
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Keeler Optical Products , Ltd.
- Date Received
- November 8, 1978
- Decision Date
- December 4, 1978
- Product Code
- HPM
- 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 |
|---|---|---|---|
| HPM | Locator, Metal, Electronic | FDA class 2 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HPM), ordered by most recent decision date.
PEDIATRIC INGESTASCAN
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SHADOW MEDAL LOCATOR
FDA 510(k)
FDA Class 2
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PMT METAL LOCATOR, MODEL 3630-1
FDA 510(k)
FDA Class 2
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Other Clearances by Keeler Optical Products , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K810403 | KEELER/KONAN SPECULAR MICROSCOPE | May 13, 1981 | Substantially Equivalent |
| K801418 | KEELER AMOILS ACULL CRYO OPHTHALMIC UNIT | Jul 21, 1980 | Substantially Equivalent |
| K792255 | NEVYAS AUTOPRESS EYE COMPRESSOR | Dec 11, 1979 | Substantially Equivalent |
| K782141 | LEVIGATOR, KEELER PHOKO | Jan 26, 1979 | Substantially Equivalent |