MAYFIELD TABLE-ELECTRIC— 510(k) K851021
Substantially EquivalentOhio Medical Instrument Co., Inc.
FDA 510(k) clearance K851021 for MAYFIELD TABLE-ELECTRIC, Substantially Equivalent on 1985-05-21. Applicant: Ohio Medical Instrument Co., Inc.. Device class: 1.
Clearance details
- Applicant
- Ohio Medical Instrument Co., Inc.
- Product code
- Code GDC
- Device class
- Class 1
- Regulation
- 21 CFR 878.4960
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cincinnati, OH, US
Recent devices under product code GDC
view allMore clearances from Ohio Medical Instrument Co., Inc.
view all- K021604 — MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020
- K013428 — MAYFIELD/ACCISS OPERATING ARM SYSTEM AND MAYFIELD/OPTICAL ACCISS SYSTEM
- K992843 — THE MAYFIELD / ACCISS SYSTEM WITH WINDOWS NT FOR CRANIAL SURGERY, THE MAYFIELD / OPTICAL ACCISS SYSTEM WITH WINDOWS NT F
- K991267 — SPINE APPLICATIONS FOR THE MAYFIELD/ACCISS OPERATING ARM AND OPTICAL ACCISS SYSTEMS MODULE, MAYFIELD/ACCISS SPINE RING A
- K983282 — OMI OCCIPITAL CERVICAL LOOP, MODEL A1089
Adverse events under product code GDC
product code GDC- Malfunction
- 791
- Total
- 791
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.