FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SONOPREP IMPEDANCE DIAGNOSTICS (IDX) SYSTEM, MODEL D1000
K Number: K023713
·
Decision Jan 28, 2004
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
10
Applicant Total
2
Review Days
450
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Basic Information
- Device Name
- SONOPREP IMPEDANCE DIAGNOSTICS (IDX) SYSTEM, MODEL D1000
- K Number
- K023713
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2370
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sontra Medical, Inc.
- Date Received
- November 4, 2002
- Decision Date
- January 28, 2004
- Product Code
- KRC
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| KRC | Tester, Electrode, Surface, Electrocardiographic | FDA class 2 | Cardiovascular |
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Other Clearances by Sontra Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K040525 | SONOPREP ULTRASONIC SKIN PERMEATION SYSTEM AND TOPICAL ANESTHETIC KIT, MODEL D2000 | Aug 17, 2004 | Unknown |