FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
U.I. OCTOSON
K Number: K801675
·
Decision Oct 23, 1980
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
80
Applicant Total
27
Review Days
93
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Basic Information
- Device Name
- U.I. OCTOSON
- K Number
- K801675
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4635
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Ausonics Pty , Ltd.
- Date Received
- July 22, 1980
- Decision Date
- October 23, 1980
- Product Code
- LEJ
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| LEJ | Booth, Sun Tan | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Ausonics Pty , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K933916 | AUSONICS OPUS 2 REALTIME ULTRASOUND SCANNER | Oct 3, 1994 | Substantially Equivalent |
| K915715 | CINE RECALL FUNCTION/OPUS 1 REAL TIME SCANNER | Jul 2, 1992 | Substantially Equivalent |
| K920307 | AUSONICS OPUS 1 SYSTEM, ANNULAR ARRAY OPTION | May 19, 1992 | Substantially Equivalent |
| K905488 | DOPPLER UPGRADE FOR AUSONICS OPUS 1 REAL TIME SCAN | Dec 18, 1991 | Substantially Equivalent |
| K902728 | 7.5 MHZ BI PLANE RECTAL PROBE (P/N: 041-815) | Feb 13, 1991 | Substantially Equivalent |
| K896714 | AUSONICS 5000 | Jun 11, 1990 | Substantially Equivalent |
| K881979 | RESUBMITTAL OF MI 1000C MICROIMAGER | Jun 12, 1989 | Substantially Equivalent |
| K884299 | APA-C CATALOG NUMBER A-8001-C | Jan 10, 1989 | Substantially Equivalent |
| K883925 | UROIMAGER | Dec 15, 1988 | Substantially Equivalent |
| K883079 | WWDS-005 HUMAN RECTAL PROBE | Dec 14, 1988 | Substantially Equivalent |