9380 Digital Capture Module
Pentax of America, Inc. · 2 device(s)
Regulatory coverage
2 certification typesThe same product registered across multiple national regulators, aggregated into a single coverage view.
- MFDSCleared
- FDA 510(k)Cleared
- FDA PMANot listed
- FDA De NovoNot listed
- CE-MDRNot listed
- PMDANot listed
- NMPANot listed
- TGANot listed
- Health CanadaNot listed
- HSANot listed
- ANVISANot listed
Grouped devices
Certification records for each registration, shown as published by the regulator. Fields the regulator does not provide are omitted.
- 의료영상 처리장치PENTAX of America, Inc.
- MFDS
수신 24-781 호2024-05-02ValidClass 1Indications: 의료용 영상을 저장, 확대, 축소, 조회 등을 하는 장치
- Pentax of AmericaPENTAX OF AMERICA, INC.
- FDA 510(k)
049613332481172022-11-04ValidClass 1