FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OB TILT TABLE
K Number: K823149
·
Decision Nov 5, 1982
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
34
Applicant Total
11
Review Days
16
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Basic Information
- Device Name
- OB TILT TABLE
- K Number
- K823149
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3750
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Orthion Corp.
- Date Received
- October 20, 1982
- Decision Date
- November 5, 1982
- Product Code
- INW
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| INW | Table, Mechanical | FDA class 1 | Physical Medicine |
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Other Clearances by Orthion Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K832546 | MARK V HIGH VOLTAGE GALVANIC STIMULATORR | Oct 14, 1983 | Substantially Equivalent |
| K823152 | OB HELP ARM | Nov 5, 1982 | Substantially Equivalent |
| K823151 | OB TRIPP TRANSPORT CHAIR | Nov 5, 1982 | Substantially Equivalent |
| K823150 | SESAM TREATMENT TABLE | Nov 5, 1982 | Substantially Equivalent |
| K823156 | COLLAPSABLE LAVATORY HEIGHTENER | Nov 5, 1982 | Substantially Equivalent |
| K823105 | RESI-WALKER | Nov 5, 1982 | Substantially Equivalent |
| K823154 | SHOWER STOOL W/HANDLES | Nov 5, 1982 | Substantially Equivalent |
| K823155 | LAVATORY SEAT HEIGHTENER | Nov 5, 1982 | Substantially Equivalent |
| K823153 | BATH TUB SEAT & BATH BOARD | Nov 5, 1982 | Substantially Equivalent |
| K812701 | ORTHO-THERM INFRARED SENSOR | Oct 13, 1981 | Substantially Equivalent |