Prolong-Ex, Models: PLEX-50CS, PLEX-100CS, PLEX-150CS
FDA 510(k) K072050 · Life-Tech, Inc.
510(k) numberK072050
Submission
- Device name
- Prolong-Ex, Models: PLEX-50CS, PLEX-100CS, PLEX-150CS
- Applicant
- Life-Tech, Inc.
Stafford, TX, US - Received
- July 26, 2007
- Decision date
- October 18, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- BSO – Catheter, Conduction, Anesthetic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5120
- Specialty
- Anesthesiology
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| K093662 | EchobrightCAZ · Traditional | 06/24/2010SE |
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| K082772 | Stimpro, Models SP22050, SP20100, SPP19050, SPP19100, SPP19150, SPC19050, SPC19100…BSP · Traditional | 02/09/2009SE |
| K082056 | Anorectal Manometry Software Option ARM-1FFX · Traditional | 11/07/2008SE |
| K082923 | Prlong, Models PL50, PL100, PL-40C, PL-50C, PL-100C, PL-150C, PLT-40C, PLT-50C…CAC · Special | 10/24/2008SE |
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Questions and answers
When was Prolong-Ex, Models: PLEX-50CS, PLEX-100CS, PLEX-150CS cleared by the FDA?
Prolong-Ex, Models: PLEX-50CS, PLEX-100CS, PLEX-150CS (K072050) received a 510(k) decision of Substantially Equivalent on October 18, 2007, 84 days after the submission was received.
What is the product code of K072050?
The FDA product code is BSO – Catheter, Conduction, Anesthetic, a Class II (moderate risk) device regulated under 21 CFR 868.5120.