FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ESCOTEK-EST 301A ULTRA-SONIC UNIT
K Number: K844386
·
Decision May 1, 1985
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
88
Applicant Total
7
Review Days
169
Basic Information
- Device Name
- ESCOTEK-EST 301A ULTRA-SONIC UNIT
- K Number
- K844386
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5300
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- NOR-AM PATIENT CARE PRODUCTS, INC.
- Date Received
- November 13, 1984
- Decision Date
- May 1, 1985
- Product Code
- IMI
- 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 |
|---|---|---|---|
| IMI | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | FDA class 2 | Physical Medicine |
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Other Clearances by NOR-AM PATIENT CARE PRODUCTS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K900647 | SOUTHERN CROSS HI-V4 PULSED HIGH VOLTAGE GALVANIC | Oct 22, 1990 | Substantially Equivalent |
| K844390 | ESCOTEK-EST 204 MULTI STIM | May 7, 1985 | Substantially Equivalent |
| K844389 | ESCOTEK EST 210, HIGH VOLTAGE ELECTRO GALVANIC STI | May 7, 1985 | Substantially Equivalent |
| K844388 | ESCOTEK EST 220 INTERFERENCE THERAPY UNIT | May 7, 1985 | Substantially Equivalent |
| K844387 | ESCOTEK-EST 221 VACUUM UNIT | May 7, 1985 | Substantially Equivalent |
| K844385 | ESCOTEK EST TRAC 401 | May 1, 1985 | Substantially Equivalent |