FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
THE SPIRA ELEKTRO 2
K Number: K871151
·
Decision May 15, 1987
Classifications
1
FEI Numbers
140
Registration Numbers
140
Same Product Code
61
Applicant Total
14
Review Days
53
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Basic Information
- Device Name
- THE SPIRA ELEKTRO 2
- K Number
- K871151
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5640
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Warren E. Collins, Inc.
- Date Received
- March 23, 1987
- Decision Date
- May 15, 1987
- Product Code
- CCQ
- 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 |
|---|---|---|---|
| CCQ | Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | FDA class 1 | Anesthesiology |
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Other Clearances by Warren E. Collins, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K925459 | GS-MODULAR (GOLD STANDARD - MODULAR) | Feb 4, 1994 | Substantially Equivalent |
| K912946 | COLLINS DIGITAL PULMONARY MANOMETER | Jan 15, 1992 | Substantially Equivalent |
| K861227 | COLLINS PNEUMOTACH PFT SYSTEM | Jun 5, 1986 | Substantially Equivalent |
| K852102 | COLLIN BODY PLETHYSMOGRAPH PLUS SYSTEM | Jul 31, 1985 | Substantially Equivalent |
| K831780 | METABOLIC EXERCISE TESTING SYSTEM | Sep 12, 1983 | Substantially Equivalent |
| K831777 | COLLINS DS | Aug 31, 1983 | Substantially Equivalent |
| K831778 | RS-RESIDUAL VOLUME SYSTEM | Aug 31, 1983 | Substantially Equivalent |
| K831779 | COLLINS EAGLE II | Aug 26, 1983 | Substantially Equivalent |
| K803053 | APEXLINE OF PULMONARY FUNCT. INSTRUM. | Dec 22, 1980 | Substantially Equivalent |
| K803069 | SHELL KRATON THERMO-PLASTIC RUBBER COMP. | Dec 22, 1980 | Substantially Equivalent |