FDA 510(k)
FDA class 1
Unknown
🇺🇸 United States
ANESTHESIA RESPIRATORY BREATH CIRCUIT PACKS/COMPON
K Number: K926454
·
Decision Jun 22, 1993
Classifications
1
FEI Numbers
199
Registration Numbers
199
Same Product Code
183
Applicant Total
21
Review Days
180
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Basic Information
- Device Name
- ANESTHESIA RESPIRATORY BREATH CIRCUIT PACKS/COMPON
- K Number
- K926454
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5240
- Medical Specialty
- Anesthesiology
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- Medical, Inc.
- Date Received
- December 24, 1992
- Decision Date
- June 22, 1993
- Product Code
- CAI
- 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 |
|---|---|---|---|
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CAI), ordered by most recent decision date.
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Other Clearances by Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K894839 | OS-1 OCCLUSION SYSTEM - 1 | Oct 24, 1989 | Substantially Equivalent |
| K872001 | MODEL TPC-1A OXYGEN ANALYZER | Jun 15, 1987 | Substantially Equivalent |
| K863806 | MODEL A-1 OXYGEN ANALYZER | Oct 15, 1986 | Substantially Equivalent |
| K862591 | INTERFACE ARTERIAL BLOOD FILTER, MODEL 42 | Sep 4, 1986 | Substantially Equivalent |
| K862609 | INTERFACE ARTERIAL BLOOD FILTER, MODEL 44 | Sep 4, 1986 | Substantially Equivalent |
| K861226 | INTERFACE CRYSTALLOID CARDIOPLEGIC FILTER MODEL 70 | Jun 2, 1986 | Substantially Equivalent |
| K851370 | INTERFACE TRANSFUSION BLOOD FILTER #35 | Jun 27, 1985 | Substantially Equivalent |
| K823261 | INTERFACE TRANSFUSION BLOOD FILTER #30 | Jan 7, 1983 | Substantially Equivalent |
| K823258 | INTERFACE ARTERIAL BLOOD FILTER #40 | Nov 24, 1982 | Substantially Equivalent |
| K823260 | INTERFACE CARDIOTOMY BLOOD FILTER #51 | Nov 24, 1982 | Substantially Equivalent |