INSIGHT 4000 ENDOSCOPE— 510(k) K000252
Substantially EquivalentInsight Instruments Mfg., Inc.
FDA 510(k) clearance K000252 for INSIGHT 4000 ENDOSCOPE, Substantially Equivalent on 2000-10-17. Applicant: Insight Instruments Mfg., Inc.. Device class: 2.
Clearance details
- Applicant
- Insight Instruments Mfg., Inc.
- Product code
- Code MPA
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sanford, FL, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.