FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PASSY-MUIR LOW-PROFILE TRACHEOSTOMY SPEAKING VALVE PMV 2020 (CLEAR) JIT
K Number: K990905
·
Decision Jun 11, 1999
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
108
Applicant Total
5
Review Days
85
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Basic Information
- Device Name
- PASSY-MUIR LOW-PROFILE TRACHEOSTOMY SPEAKING VALVE PMV 2020 (CLEAR) JIT
- K Number
- K990905
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5800
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Passy-Muir, Inc.
- Date Received
- March 18, 1999
- Decision Date
- June 11, 1999
- Product Code
- JOH
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| JOH | Tube Tracheostomy And Tube Cuff | FDA class 2 | Anesthesiology |
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Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Distal with Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Proximal with Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley Adult Flexible Disposable Inner Cannula XLT
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Other Clearances by Passy-Muir, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K230483 | Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15) | Sep 16, 2023 | Substantially Equivalent |
| K970365 | PASSY-MUIR O2 ADAPTER; PMA2000 | Feb 12, 1997 | Substantially Equivalent |
| K962714 | PASSY-MUIR LOW-PROFILE TRACHEOSTOMY AND VENTILATOR SPEAKING VALVE; PRODUCT NUMBER PMV 2000 OR PMTSV 2000 | Oct 28, 1996 | Substantially Equivalent |
| K944451 | PASSY-MUIR TRACHEOSTOMY SPEAKING VALVES (ONE-WAY TRACHEOSTOMY SPEAKING VALVES) | Jul 7, 1995 | Substantially Equivalent |