ISIS
FDA 510(k) clearance K844736 · decided 1985-03-21
Clearance details
- K-number
- K844736
- Device name
- ISIS
- Applicant
- Oxford Medilog, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-12-05
- Decision date
- 1985-03-21
- Days to decision
- 106 days
- Clearance type
- Traditional
- Product code
- LDK
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Clearwater, FL, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
| NSite Scoliosis Assessment App (K230463) | Nsite, Inc. | 2023-11-15 |
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| QUANTEC SPINAL MEASUEMENT SYSTEM (K923792) | Quantec Image Processing , Ltd. | 1994-04-20 |
| METRICOM (K860225) | Far Orthopedics, Inc. | 1986-02-11 |
| TERRAN BIOMECHANICAL ANALYSIS SYSTEM (K851133) | Terran Biomedical Instruments | 1985-06-19 |
| CONTOUROGRAPH M-500 (K800591) | Bio-Tek Instruments, Inc. | 1980-04-02 |
Recalls involving this device
No recalls on record reference this clearance.