Clip, Nose
The Clip, Nose is a simple device applied externally to occlude the nostrils, typically used in pulmonary function testing to prevent nasal breathing and ensure all respiratory flow passes through the mouth and measurement device. It is classified as FDA Class 1, the lowest risk category, subject to general controls only. The product code is BXJ, regulated under 21 CFR 868.6225 in the Anesthesiology specialty. This device is exempt from Good Manufacturing Practice (GMP) requirements.
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Basic Information
- Product Code
- BXJ
- Device Class
- FDA class 1
- Regulation Number
- 868.6225
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K853578 | MEDIPART DISPOS. NOSE CLIP MP-2001 | Oct 29, 1985 | Substantially Equivalent | Medipart Jerry Alexander |
| K810339 | NOSECLIP #6118 | Mar 17, 1981 | Substantially Equivalent | Todd Industries, Inc. |
| K770015 | NOSECLIP FOR RESP. CARE & PULMON. FUNC. | Mar 16, 1977 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K760461 | NOSE CLIP | Aug 26, 1976 | Substantially Equivalent | Inspiron Corp. |
FEI Numbers
This FDA classification entry is associated with 62 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 62 registration numbers. Click on an entry to view related FDA registrations.