FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BLOM-SINGER INDWELLING LOW PRESSURE VOICE PROSTHES
K Number: K932120
·
Decision Apr 15, 1994
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
39
Applicant Total
14
Review Days
347
Basic Information
- Device Name
- BLOM-SINGER INDWELLING LOW PRESSURE VOICE PROSTHES
- K Number
- K932120
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3730
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- HELIX MEDICAL, INC.
- Date Received
- May 3, 1993
- Decision Date
- April 15, 1994
- Product Code
- EWL
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EWL | Prosthesis, Laryngeal (Taub) | FDA class 2 | Ear, Nose, Throat |
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Other Clearances by HELIX MEDICAL, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K023259 | INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200 | Dec 26, 2002 | Substantially Equivalent |
| K991587 | BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS | Jun 25, 1999 | Substantially Equivalent |
| K945287 | INHEALTH BLOM-SINGER INDWELLING VALVED INSERT ACCESSORY DEVICE | Dec 9, 1994 | Substantially Equivalent |
| K945288 | INHEALTH BLOM-SINGER INDWELLING PLUG INSERT ACCESSORY DEVICE | Dec 2, 1994 | Substantially Equivalent |
| K932163 | BLOM-SINGER VOICE PROSTHESIS FLUSHING PIPET | Dec 15, 1993 | Substantially Equivalent |
| K930105 | BLOM-SINGER LOW PRESSURE VOICE PROSTHESIS,P.I.D.S. | May 17, 1993 | Substantially Equivalent |
| K920090 | BLOM-SINGER TRACHEOESOPHAGEAL PUNCTURE SET | Sep 10, 1992 | Substantially Equivalent |
| K915786 | BLOM-SINGER HUMID/FIL SYST INHEALTH IN-LINE HUMID. | Jun 30, 1992 | Substantially Equivalent |
| K904729 | BLOM-SINGER SHOWER GUARD | Feb 28, 1991 | Substantially Equivalent |
| K902112 | BLOM-SINGER(R) TRACHEOESOPHAGEAL FISTULA STENT | Aug 1, 1990 | Substantially Equivalent |