ENDOSCOPE— 510(k) K964131
Substantially EquivalentAkos Biomedical, Inc.
FDA 510(k) clearance K964131 for ENDOSCOPE, Substantially Equivalent on 1997-06-27. Applicant: Akos Biomedical, Inc.. Device class: 2.
Clearance details
- Applicant
- Akos Biomedical, Inc.
- Product code
- Code FAM
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Recent devices under product code FAM
view all- K970382 — VS-100 VIDEO SIGMOIDOSCOPE
- K964326 — VISION-SCIENCES MODEL S-V200 COLOR MVIDEO FLEXIBLE SIGMOIDOSCOPE WITH ENDOSHEATH SYSTEM
- K964100 — VISION-SCIENCES MODEL SS-U32 ENDO SHEATH FOR USE WITH THE VSI S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE AND VSI S-V100
- K963344 — DISPOSABLE SS-F32 ENDOSHEATH FOR USE WITH THE S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE
- K961567 — ES-3840, VIDEO SIGMOIDOSCOPE
Data sourced from openFDA. This site is unofficial and independent of the FDA.