FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
ACU-BAND ACCUPRESSURE WRIST BAND
K Number: K900588
·
Decision Feb 22, 1990
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
12
Applicant Total
2
Review Days
15
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Basic Information
- Device Name
- ACU-BAND ACCUPRESSURE WRIST BAND
- K Number
- K900588
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Euro-Am Pharma, Inc.
- Date Received
- February 7, 1990
- Decision Date
- February 22, 1990
- Product Code
- MVV
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| MVV | Device, Acupressure | FDA unclassified | Unknown |
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Other Clearances by Euro-Am Pharma, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K912620 | OPOMAT MANUAL RESUSCITATOR VENTILATOR | Dec 4, 1991 | Substantially Equivalent |