FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PeDIA
K Number: K181424
·
Decision Sep 25, 2018
Classifications
1
FEI Numbers
94
Registration Numbers
94
Same Product Code
18
Applicant Total
1
Review Days
117
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Basic Information
- Device Name
- PeDIA
- K Number
- K181424
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5320
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pedia, LLC
- Date Received
- May 31, 2018
- Decision Date
- September 25, 2018
- Product Code
- BTC
- 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 |
|---|---|---|---|
| BTC | Bag, Reservoir | FDA class 1 | Anesthesiology |
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