MAXAIR SURGICAL HELMET SYSTEM— 510(k) K040485
Substantially EquivalentBio-Medical Devices, Inc.
FDA 510(k) clearance K040485 for MAXAIR SURGICAL HELMET SYSTEM, Substantially Equivalent on 2004-10-18. Applicant: Bio-Medical Devices, Inc.. Device class: 2.
Clearance details
- Applicant
- Bio-Medical Devices, Inc.
- Product code
- Code FYA
- Device class
- Class 2
- Regulation
- 21 CFR 878.4040
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Recent devices under product code FYA
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- K261949 — NYES Tuff Cuff L3 Disposable Gowns
- K252575 — Tuff Cuff Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)
- K260725 — BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)
More clearances from Bio-Medical Devices, Inc.
view allRecalls naming K040485
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K040485.
Data sourced from openFDA. This site is unofficial and independent of the FDA.