FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INSPECTRA TISSUE SPECTROMETER SYSTEM, MODEL 325
K Number: K053618
·
Decision Feb 8, 2006
Classifications
1
FEI Numbers
58
Registration Numbers
58
Same Product Code
73
Applicant Total
8
Review Days
42
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Basic Information
- Device Name
- INSPECTRA TISSUE SPECTROMETER SYSTEM, MODEL 325
- K Number
- K053618
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2700
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hutchinson Technology, Inc.
- Date Received
- December 28, 2005
- Decision Date
- February 8, 2006
- Product Code
- MUD
- 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 |
|---|---|---|---|
| MUD | Oximeter, Tissue Saturation | FDA class 2 | Cardiovascular |
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Other Clearances by Hutchinson Technology, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K103613 | INPECTRA STO2 SPOT CHECK | Mar 2, 2011 | Substantially Equivalent |
| K100915 | INSPECTRA STO2 TISSUE OXYGENATION MONITOR, MODEL 650 | Apr 30, 2010 | Substantially Equivalent |
| K061619 | INSPECTRA STO2 TISSUE OXYGENATION MONITOR | Jul 12, 2006 | Substantially Equivalent |
| K042020 | SPECTRA TISSUE SPECTROMETER SYSTEM (INSPECTRA) | Sep 15, 2004 | Substantially Equivalent |
| K023938 | MODIFICATION TO INSPECTRA TISSUE SPECTROMETER SYSTEM, MODEL 325 | Dec 13, 2002 | Substantially Equivalent |
| K012759 | INSPECTRA TISSUE SPECTROMETER SYSTEM (INSPECTRA), MODEL 325 | Jan 17, 2002 | Substantially Equivalent |
| K963903 | BIOSPECTROMETER-NB OXIMETER IIII | Jan 27, 1998 | Substantially Equivalent |