FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COLLINS CPL
K Number: K992743
·
Decision Sep 13, 1999
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
227
Applicant Total
4
Review Days
28
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Basic Information
- Device Name
- COLLINS CPL
- K Number
- K992743
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 868.1840
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Collins Medical, Inc.
- Date Received
- August 16, 1999
- Decision Date
- September 13, 1999
- Product Code
- BZG
- 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 |
|---|---|---|---|
| BZG | Spirometer, Diagnostic | FDA class 2 | Anesthesiology |
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Other Clearances by Collins Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K030917 | GEM; HAWK; EAGLE; MODELS 004110, 0044120, 004130 | May 14, 2003 | Substantially Equivalent |
| K030464 | GEM, MODEL 004110 | Mar 14, 2003 | Substantially Equivalent |
| K011344 | INFANT PLETHYSMOGRAPH, MODEL 004400; PEDIATRIC PLETHYSMOGRAPH, MODEL 004400 | May 17, 2002 | Substantially Equivalent |