FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HF MODULE WITH TRANSDUCERS
K Number: K031391
·
Decision Jun 20, 2003
Classifications
1
FEI Numbers
348
Registration Numbers
349
Same Product Code
892
Applicant Total
9
Review Days
49
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Basic Information
- Device Name
- HF MODULE WITH TRANSDUCERS
- K Number
- K031391
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1560
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ophthalmic Technologies, Inc.
- Date Received
- May 2, 2003
- Decision Date
- June 20, 2003
- Product Code
- IYO
- Advisory Committee
- Radiology
- 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 |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | FDA class 2 | Radiology |
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Other Clearances by Ophthalmic Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K042885 | OCT-OPTHALMOSCOPE | Jan 21, 2005 | Substantially Equivalent |
| K030770 | OTI SCAN WITH TRANSDUCERS | Mar 27, 2003 | Substantially Equivalent |
| K024114 | A-SCAN 100 | Jan 10, 2003 | Substantially Equivalent |
| K990064 | DI-RHEX OPHTHALMIC DIATHERMY SYSTEM | Apr 4, 1999 | Substantially Equivalent |
| K974522 | 3D I-SCAN | Feb 25, 1998 | Substantially Equivalent |
| K971679 | I-SCOPE OPHTHALMIC ENDOSCOPE | Jun 25, 1997 | Substantially Equivalent |
| K960622 | I-SCAN | May 13, 1996 | Substantially Equivalent |
| K954263 | XE-LITE | Oct 18, 1995 | Unknown |