FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IOB Warming Blankets
K Number: K221669
·
Decision Dec 27, 2022
Classifications
1
FEI Numbers
90
Registration Numbers
90
Same Product Code
157
Applicant Total
7
Review Days
201
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Basic Information
- Device Name
- IOB Warming Blankets
- K Number
- K221669
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5900
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Iob Medical, Inc.
- Date Received
- June 9, 2022
- Decision Date
- December 27, 2022
- Product Code
- DWJ
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DWJ | System, Thermal Regulating | FDA class 2 | Cardiovascular |
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Other Clearances by Iob Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K232638 | FilteredFlo Warming Blankets | Oct 24, 2023 | Substantially Equivalent |
| K231596 | IOB Temperature Management System | Jun 30, 2023 | Substantially Equivalent |
| K201896 | ivi N3003 Surgical face Mask, ivi N6006 Surgical mask | Mar 30, 2021 | Substantially Equivalent |
| K190221 | IOB Warming Blankets | Oct 25, 2019 | Substantially Equivalent |
| K162679 | IOB Temperature Management System | Apr 28, 2017 | Substantially Equivalent |
| K132668 | IOB DISPOSABLE SPECULUM | Jan 17, 2014 | Substantially Equivalent |