FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ECG & ULTRASOUND GELS, CREAMS & LOTION
K Number: K803151
·
Decision Dec 30, 1980
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
68
Applicant Total
127
Review Days
18
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Basic Information
- Device Name
- ECG & ULTRASOUND GELS, CREAMS & LOTION
- K Number
- K803151
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1275
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Abco Dealers, Inc.
- Date Received
- December 12, 1980
- Decision Date
- December 30, 1980
- Product Code
- GYB
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| GYB | Media, Electroconductive | FDA class 2 | Neurology |
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|---|---|---|---|
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| K872875 | STRETCH GAUZE BANDAGES | Sep 4, 1987 | Substantially Equivalent |
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| K871465 | THERMOMETER SHEATHS | May 11, 1987 | Substantially Equivalent |
| K862726 | DISPOSABLE SHOE COVERS AND NURSES CAPS | Aug 1, 1986 | Substantially Equivalent |
| K862111 | ARMBOARDS, REUSABLE AND DISPOSABLE | Jul 8, 1986 | Substantially Equivalent |