ROUND WINDOW E-CATH— 510(k) K973740
Substantially EquivalentNeuro-Biometrix, Inc.
FDA 510(k) clearance K973740 for ROUND WINDOW E-CATH, Substantially Equivalent on 1998-03-23. Applicant: Neuro-Biometrix, Inc.. Device class: 2.
Clearance details
- Applicant
- Neuro-Biometrix, Inc.
- Product code
- Code ETD
- Device class
- Class 2
- Regulation
- 21 CFR 874.3880
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Englewood, CO, US
Recent devices under product code ETD
view all- K252436 — Tula Tympanostomy Tube Delivery Device
- K250256 — Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000))
- K232702 — Solo+ Tympanostomy Tube Device (TTD)
- K233658 — Biowy Tym Tube (TT)
- K232059 — Tympanostomy Tubes
More clearances from Neuro-Biometrix, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.