510(k) K910212
K910212 is an FDA 510(k) premarket notification submitted by Acoustic Imaging Technologies Corp. for the device "COLOR DOPPLER OPTION TO AI 5200 DIAG ULTRASO SYST". The FDA issued a decision of Substantially Equivalent on July 11, 1991. The device falls under product code JYO (Knife, Ear), a Class I device regulated under 21 CFR 874.4420. Acoustic Imaging Technologies Corp. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 11, 1991
- Date Received
- January 15, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Knife, Ear
- Device Class
- Class I
- Regulation Number
- 874.4420
- Review Panel
- EN
- Submission Type