FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PRLONG, MODELS PL50, PL100, PL-40C, PL-50C, PL-100C, PL-150C, PLT-40C, PLT-50C, PLT-100C, PLT-150C
K Number: K082923
·
Decision Oct 24, 2008
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
194
Applicant Total
14
Review Days
23
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Basic Information
- Device Name
- PRLONG, MODELS PL50, PL100, PL-40C, PL-50C, PL-100C, PL-150C, PLT-40C, PLT-50C, PLT-100C, PLT-150C
- K Number
- K082923
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 868.5830
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Life-Tech, Inc.
- Date Received
- October 1, 2008
- Decision Date
- October 24, 2008
- Product Code
- CAC
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| CAC | Apparatus, Autotransfusion | FDA class 2 | Anesthesiology |
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Other Clearances by Life-Tech, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K120234 | EZONO 3000 | Apr 19, 2012 | Substantially Equivalent |
| K111355 | ECHOBRIGHT | Sep 16, 2011 | Substantially Equivalent |
| K102813 | EZONO 3000 | Jun 30, 2011 | Substantially Equivalent |
| K102007 | PROLONG, MODELS PL 18040TC, PL18050TGC, PL18100TGC, PL18150TGC, | Dec 22, 2010 | Substantially Equivalent |
| K093662 | ECHOBRIGHT | Jun 24, 2010 | Substantially Equivalent |
| K093485 | VESISCAN | Mar 16, 2010 | Substantially Equivalent |
| K082772 | STIMPRO, MODELS SP22050, SP20100, SPP19050, SPP19100, SPP19150, SPC19050, SPC19100, SPC19150, SPC18050,SPC18100,SPC18150 | Feb 9, 2009 | Substantially Equivalent |
| K082056 | ANORECTAL MANOMETRY SOFTWARE OPTION ARM-1 | Nov 7, 2008 | Substantially Equivalent |
| K081864 | PROLONG | Sep 25, 2008 | Substantially Equivalent |
| K073187 | PERIPHERAL NERVE BLOCK SUPPORT TRAY | Apr 22, 2008 | Substantially Equivalent |