FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INFRA-LINK
K Number: K926029
·
Decision Mar 26, 1993
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
23
Applicant Total
6
Review Days
115
Basic Information
- Device Name
- INFRA-LINK
- K Number
- K926029
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3725
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ZYGO INDUSTRIES, INC.
- Date Received
- December 1, 1992
- Decision Date
- March 26, 1993
- Product Code
- IQA
- 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 |
|---|---|---|---|
| IQA | System, Environmental Control, Powered | FDA class 2 | Physical Medicine |
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Other Clearances by ZYGO INDUSTRIES, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K924014 | SECRETARY | Mar 4, 1993 | Substantially Equivalent |
| K924013 | MACAW | Mar 4, 1993 | Substantially Equivalent |
| K924015 | PARROT | Mar 4, 1993 | Substantially Equivalent |
| K924030 | SCRIBE | Mar 4, 1993 | Substantially Equivalent |
| K862766 | EPISON, ALERTING SYSTEM FOR EPILEPTICS | Mar 13, 1987 | Substantially Equivalent |