510(k) K991562
K991562 is an FDA 510(k) premarket notification submitted by Pascal Medical AB for the device "PASCAL MEDICAL AB MENIETT 20". The FDA issued a decision of Substantially Equivalent on December 28, 1999. The device falls under product code ETY (Tester, Auditory Impedance), a Class II device regulated under 21 CFR 874.1090.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 28, 1999
- Date Received
- May 4, 1999
- 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