Last synced on 30 November 2024 at 11:09 am

Endoscopic Video Image Processor (RP-IPD-V2000A, RP-IPD-V2000B, RP-IPD-V2000C, RP-IPD-V2000D), Single-Use Video Gastroscope (RP-GI-G02A, RP-GI-G02B), Single-Use Video Colonoscope (RP-GI-C02A, RP-GI-C02B)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K232043
510(k) Type
Traditional
Applicant
Guangzhou Red Pine Medical Instrument Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
2/16/2024
Days to Decision
221 days
Submission Type
Summary

Endoscopic Video Image Processor (RP-IPD-V2000A, RP-IPD-V2000B, RP-IPD-V2000C, RP-IPD-V2000D), Single-Use Video Gastroscope (RP-GI-G02A, RP-GI-G02B), Single-Use Video Colonoscope (RP-GI-C02A, RP-GI-C02B)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K232043
510(k) Type
Traditional
Applicant
Guangzhou Red Pine Medical Instrument Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
2/16/2024
Days to Decision
221 days
Submission Type
Summary