The following data is part of a premarket notification filed by Highland Instruments with the FDA for Highland Instruments Ces And Tus Instrument Holder.
Device ID | K110752 |
510k Number | K110752 |
Device Name: | HIGHLAND INSTRUMENTS CES AND TUS INSTRUMENT HOLDER |
Classification | Transducer, Ultrasonic, Diagnostic |
Applicant | HIGHLAND INSTRUMENTS 755 WESTMINSTER STREET UNIT 120 Providence, RI 02903 |
Contact | Leo Basta |
Correspondent | Leo Basta HIGHLAND INSTRUMENTS 755 WESTMINSTER STREET UNIT 120 Providence, RI 02903 |
Product Code | ITX |
CFR Regulation Number | 892.1570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-03-18 |
Decision Date | 2011-06-28 |
Summary: | summary |