FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CIRCAPAK UNIVERSAL VOLUME VENTILATOR CIRCUIT
K Number: K861555
·
Decision Jun 5, 1986
Classifications
1
FEI Numbers
118
Registration Numbers
118
Same Product Code
459
Applicant Total
26
Review Days
41
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Basic Information
- Device Name
- CIRCAPAK UNIVERSAL VOLUME VENTILATOR CIRCUIT
- K Number
- K861555
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5905
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Respiratory Care, Inc.
- Date Received
- April 25, 1986
- Decision Date
- June 5, 1986
- Product Code
- BZD
- 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 |
|---|---|---|---|
| BZD | Ventilator, Non-Continuous (Respirator) | FDA class 2 | Anesthesiology |
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Other Clearances by Respiratory Care, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| K833974 | AQUAPAK 020 HUMIDIFIER ADAPTER | Dec 16, 1983 | Substantially Equivalent |
| K832453 | SLIMB SINGLE LIMB BREATHING CIRCUIT | Oct 27, 1983 | Substantially Equivalent |
| K811524 | AQUACADE | Jul 1, 1981 | Substantially Equivalent |
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