FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 1000
K Number: K982889
·
Decision Jun 1, 1999
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
57
Applicant Total
5
Review Days
288
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Basic Information
- Device Name
- MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 1000
- K Number
- K982889
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5665
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Electromed, Inc.
- Date Received
- August 17, 1998
- Decision Date
- June 1, 1999
- Product Code
- BYI
- 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 |
|---|---|---|---|
| BYI | Percussor, Powered-Electric | FDA class 2 | Anesthesiology |
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Other Clearances by Electromed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K222496 | Electromed SmartVest Airway Clearance System | Nov 18, 2022 | Substantially Equivalent |
| K132794 | SMARTVEST AIRWAY CLEARANCE SYSTEM | Dec 19, 2013 | Substantially Equivalent |
| K053248 | SMARTVEST AIRWAY CLEARANCE SYSTEM, MODEL TL | Dec 1, 2005 | Substantially Equivalent |
| K040367 | MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 2000EZ | Apr 7, 2004 | Substantially Equivalent |