BLOM-SINGER HUMID/FIL SYST INHEALTH IN-LINE HUMID.— 510(k) K915786
Substantially EquivalentHelix Medical, Inc.
FDA 510(k) clearance K915786 for BLOM-SINGER HUMID/FIL SYST INHEALTH IN-LINE HUMID., Substantially Equivalent on 1992-06-30. Applicant: Helix Medical, Inc.. Device class: 1.
Clearance details
- Applicant
- Helix Medical, Inc.
- Product code
- Code BYD
- Device class
- Class 1
- Regulation
- 21 CFR 868.5375
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Barbera, CA, US
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