FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MULTI-PULSE 2000
K Number: K001248
·
Decision May 4, 2000
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
189
Applicant Total
7
Review Days
16
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MULTI-PULSE 2000
- K Number
- K001248
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.1800
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Imaging Sciences Intl., Inc.
- Date Received
- April 18, 2000
- Decision Date
- May 4, 2000
- Product Code
- EHD
- Advisory Committee
- Dental
- 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 |
|---|---|---|---|
| EHD | Unit, X-Ray, Extraoral With Timer | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EHD), ordered by most recent decision date.
Portable Dental X-ray System Model PDX nova
FDA 510(k)
FDA Class 2
·Dental
NOMAD Pro 3
FDA 510(k)
FDA Class 2
·Dental
Dental X-RAY Unit (AJX200)
FDA 510(k)
FDA Class 2
·Dental
Portable Dental X-ray Device (GT-1)
FDA 510(k)
FDA Class 2
·Dental
Diagnostic X-Ray Equipment Model POCT22
FDA 510(k)
FDA Class 2
·Dental
Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Imaging Sciences Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K061284 | I-CAT SCANNER | Jul 3, 2006 | Substantially Equivalent |
| K051980 | DVT SCANNER | Aug 19, 2005 | Substantially Equivalent |
| K041078 | SURGPLAN AND PANPLAN | Dec 23, 2004 | Substantially Equivalent |
| K991518 | PANATOME | Jun 18, 1999 | Substantially Equivalent |
| K981466 | XR-910 | Jul 14, 1998 | Substantially Equivalent |
| K931815 | 2000 X-RAY - TOMOGRAPHIC | Aug 23, 1993 | Substantially Equivalent |