FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COMPACT SPACER
K Number: K922187
·
Decision Nov 20, 1992
Classifications
1
FEI Numbers
189
Registration Numbers
189
Same Product Code
507
Applicant Total
4
Review Days
193
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Basic Information
- Device Name
- COMPACT SPACER
- K Number
- K922187
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5630
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Glaxo, Inc.
- Date Received
- May 11, 1992
- Decision Date
- November 20, 1992
- Product Code
- CAF
- 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 |
|---|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | FDA class 2 | Anesthesiology |
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Other Clearances by Glaxo, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K954041 | G.R.E.E.N. DISPOSAL CONTAINER (NOTE: G.R.E.E.N. IS AN ACRONYM FOR GLAXO RETRIEVAL EFFORT FOR EXPENDED NEEDLES) | Oct 16, 1995 | Substantially Equivalent |
| K901803 | SYRINGE NEEDLE INTRODUCER | Nov 20, 1990 | Substantially Equivalent |
| K844169 | VOLUMATIC | Nov 9, 1984 | Substantially Equivalent |