FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SESAM TABLE
K Number: K832804
·
Decision Sep 20, 1983
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
101
Applicant Total
6
Review Days
33
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Basic Information
- Device Name
- SESAM TABLE
- K Number
- K832804
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3760
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Electro-Med Health Industries, Inc.
- Date Received
- August 18, 1983
- Decision Date
- September 20, 1983
- Product Code
- INQ
- 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 |
|---|---|---|---|
| INQ | Table, Powered | FDA class 1 | Physical Medicine |
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Other Clearances by Electro-Med Health Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K852077 | VERSA STIM 380, MUSCLE STIMULATOR | Aug 21, 1985 | Substantially Equivalent for Some Indications |
| K832371 | EGS MODEL 300 | Oct 6, 1983 | Substantially Equivalent |
| K832803 | STEAM PAK MOIST HEAT | Sep 20, 1983 | Substantially Equivalent |
| K832370 | EGS MODEL 100-2 | Sep 16, 1983 | Substantially Equivalent |
| K802107 | EGS #300 BATTERY OPER. PORTA. MUSCLE STI | Oct 3, 1980 | Substantially Equivalent |