STIMPRO, MODELS SP22050, SP20100, SPP19050, SPP19100, SPP19150, SPC19050, SPC19100, SPC19150, SPC18050,SPC18100,SPC18150
FDA 510(k) clearance K082772 · decided 2009-02-09
Clearance details
- K-number
- K082772
- Device name
- STIMPRO, MODELS SP22050, SP20100, SPP19050, SPP19100, SPP19150, SPC19050, SPC19100, SPC19150, SPC18050,SPC18100,SPC18150
- Applicant
- Life-Tech, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-09-22
- Decision date
- 2009-02-09
- Days to decision
- 140 days
- Clearance type
- Traditional
- Product code
- BSP
- Device class
- 2
- Regulation number
- 868.5150
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Stafford, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.