510(k) K871652
K871652 is an FDA 510(k) premarket notification submitted by Neurocom International, Inc. for the device "NEUROCOM PRESSURE TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on July 16, 1987. The device falls under product code ETY (Tester, Auditory Impedance), a Class II device regulated under 21 CFR 874.1090. Neurocom International, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 16, 1987
- Date Received
- April 28, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tester, Auditory Impedance
- Device Class
- Class II
- Regulation Number
- 874.1090
- Review Panel
- EN
- Submission Type