FI-10P
FDA 510(k) K951195 · Pentax Precision Instrument Corp.
510(k) numberK951195
Submission
- Device name
- FI-10P
- Applicant
- Pentax Precision Instrument Corp.
Miramar, FL, US - Received
- March 16, 1995
- Decision date
- April 6, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CAL – Laryngoscope, Non-Rigid
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5530
- Specialty
- Anesthesiology
Other 510(k)s with product code CAL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K951194 | FI-10MCAL · Traditional | Pentax Precision Instrument Corp. | 04/06/1995SE |
| K872895 | Haemonetics Cell Saver Mini Saver Auto. Blood Sys.CAL · Traditional | Haemonetics Corp. | 01/11/1988SE |
| K852994 | Reichert Flexible Laryngoscope, Model LS-11CAL · Traditional | Reichert-Jung, Inc. | 07/29/1985SE |
| K850978 | Olympus LF-1 Intubation ScopeCAL · Traditional | Olympus Corp. | 05/23/1985SE |
| K802331 | Ao Flexible Laryngoscope, #LS-7CAL · Traditional | American Optical Corp. | 10/10/1980SE |
| K801364 | Ao Stylet Laryngoscope Model SLSCAL · Traditional | American Optical Corp. | 06/17/1980SE |
| K791634 | Ao Stylet Laryngoscope, Model SLS-1CAL · Traditional | American Optical Corp. | 09/17/1979SE |
More from American Optical Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K041397 | EG-3830UTITX · Traditional | 06/09/2004SE |
| K041396 | FG-36UX Fiber Ultrasound GastroscopeITX · Traditional | 06/09/2004SE |
| K041395 | EG-3630URITX · Traditional | 06/09/2004SE |
| K031789 | EG-3830UT, Video Ultrasound GastroscopeODG · Traditional | 08/08/2003SE |
| K023401 | EG-3830UT, Video Ultrasound GastroscopeODG · Traditional | 02/11/2003SE |
| K023376 | EB-1830T3, Video BronchoscopeEOQ · Special | 10/16/2002SE |
| K021276 | FG-36UX Fiber Ultrasound GastroscopeODG · Traditional | 09/12/2002SE |
| K021278 | EG-3630UR, Ultrasound Video GastroscopeODG · Traditional | 09/06/2002SE |
| K013640 | EG-3630UR, Ultrasund Video GastroscopeFDS · Traditional | 02/04/2002SE |
| K010740 | FG-36UX, Fiber Ultrasound GastroscopeODG · Traditional | 04/17/2001SE |
Questions and answers
When was FI-10P cleared by the FDA?
FI-10P (K951195) received a 510(k) decision of Substantially Equivalent on April 6, 1995, 21 days after the submission was received.
What is the product code of K951195?
The FDA product code is CAL – Laryngoscope, Non-Rigid, a Class I (low risk) device regulated under 21 CFR 868.5530.