FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PARROT
K Number: K924015
·
Decision Mar 4, 1993
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
37
Applicant Total
6
Review Days
205
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Basic Information
- Device Name
- PARROT
- K Number
- K924015
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3710
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Zygo Industries, Inc.
- Date Received
- August 11, 1992
- Decision Date
- March 4, 1993
- Product Code
- ILQ
- 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 |
|---|---|---|---|
| ILQ | System, Communication, Powered | FDA class 2 | Physical Medicine |
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Other Clearances by Zygo Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K926029 | INFRA-LINK | Mar 26, 1993 | Substantially Equivalent |
| K924013 | MACAW | Mar 4, 1993 | Substantially Equivalent |
| K924030 | SCRIBE | Mar 4, 1993 | Substantially Equivalent |
| K924014 | SECRETARY | Mar 4, 1993 | Substantially Equivalent |
| K862766 | EPISON, ALERTING SYSTEM FOR EPILEPTICS | Mar 13, 1987 | Substantially Equivalent |