BLOM-SINGER LOW PRESSURE VOICE PROSTHESIS,P.I.D.S.— 510(k) K930105
Substantially EquivalentHelix Medical, Inc.
FDA 510(k) clearance K930105 for BLOM-SINGER LOW PRESSURE VOICE PROSTHESIS,P.I.D.S., Substantially Equivalent on 1993-05-17. Applicant: Helix Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Helix Medical, Inc.
- Product code
- Code EWL
- Device class
- Class 2
- Regulation
- 21 CFR 874.3730
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Barbera, CA, US
Recent devices under product code EWL
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view all- K023259 — INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200
- K991587 — BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS
- K945287 — INHEALTH BLOM-SINGER INDWELLING VALVED INSERT ACCESSORY DEVICE
- K945288 — INHEALTH BLOM-SINGER INDWELLING PLUG INSERT ACCESSORY DEVICE
- K932120 — BLOM-SINGER INDWELLING LOW PRESSURE VOICE PROSTHES
Adverse events under product code EWL
product code EWL- Death
- 2
- Total
- 2
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.