FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
WALLACH DIGITAL IMAGING SYSTEM
K Number: K950630
·
Decision Nov 22, 1995
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
54
Applicant Total
27
Review Days
282
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Basic Information
- Device Name
- WALLACH DIGITAL IMAGING SYSTEM
- K Number
- K950630
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.2010
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Wallach Surgical Devices, Inc.
- Date Received
- February 13, 1995
- Decision Date
- November 22, 1995
- Product Code
- LMB
- 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 |
|---|---|---|---|
| LMB | Device, Digital Image Storage, Radiological | FDA class 1 | Radiology |
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Other Clearances by Wallach Surgical Devices, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K021224 | ENDOCERVICAL BLOCK NEEDLE | Jul 12, 2002 | Substantially Equivalent |
| K020711 | WALLACH LOOP ELECTRODE | Jun 3, 2002 | Substantially Equivalent |
| K000768 | WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR | Apr 11, 2000 | Substantially Equivalent |
| K992736 | WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUM | Sep 29, 1999 | Substantially Equivalent |
| K991669 | PMS 750 FINGERSWITCH | Aug 12, 1999 | Substantially Equivalent |
| K983840 | WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED) | May 20, 1999 | Substantially Equivalent |
| K984306 | `THE INSEMINATOR' (PROPOSED) | Mar 1, 1999 | Substantially Equivalent |
| K983208 | WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR | Feb 22, 1999 | Substantially Equivalent |
| K963653 | WALLACH QUANTUM 2000 ELECTROSURGICAL SYSTEM | Jun 11, 1997 | Substantially Equivalent |
| K963348 | WALLACH INTEGRATION UNIT | Mar 19, 1997 | Substantially Equivalent |