FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NESSI OTC SPACER
K Number: K101532
·
Decision Sep 1, 2010
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
1
Applicant Total
4
Review Days
90
Basic Information
- Device Name
- NESSI OTC SPACER
- K Number
- K101532
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5630
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- PHARMACARIBE
- Date Received
- June 3, 2010
- Decision Date
- September 1, 2010
- Product Code
- NVO
- 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 |
|---|---|---|---|
| NVO | Spacer, Direct Patient Interface | FDA class 2 | Anesthesiology |
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