FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MAGNETRON MUNICH MODEL ELECTRONIC CONTROL UNIT
K Number: K894511
·
Decision Oct 17, 1989
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
315
Applicant Total
6
Review Days
90
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Basic Information
- Device Name
- MAGNETRON MUNICH MODEL ELECTRONIC CONTROL UNIT
- K Number
- K894511
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4670
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Intl. Ophthalmic Industries Corp.
- Date Received
- July 19, 1989
- Decision Date
- October 17, 1989
- Product Code
- HQC
- 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 |
|---|---|---|---|
| HQC | Unit, Phacofragmentation | FDA class 2 | Ophthalmic |
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Other Clearances by Intl. Ophthalmic Industries Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K961658 | MEGATRON OPHTHALMIC SURGICAL SYSTEM | Jul 23, 1996 | Substantially Equivalent |
| K894513 | DIATHRON(R) DIATHERMY UNIT | Oct 31, 1989 | Substantially Equivalent |
| K894512 | PHACOEMULSIFICATION UNIT TO REMOVE CATARAC. LENS | Oct 17, 1989 | Substantially Equivalent |
| K823088 | ASPITRON | Apr 6, 1983 | Substantially Equivalent |
| K791763 | (MICRO-KERATRON, MICRO DUCT TREPHINE) | Nov 5, 1979 | Substantially Equivalent |