FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BREATHING FILTER FOR DISPOSABLE ANESTHESIA BREATHING CIRCUIT
K Number: K002506
·
Decision Dec 14, 2000
Classifications
1
FEI Numbers
141
Registration Numbers
141
Same Product Code
201
Applicant Total
12
Review Days
121
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Basic Information
- Device Name
- BREATHING FILTER FOR DISPOSABLE ANESTHESIA BREATHING CIRCUIT
- K Number
- K002506
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5260
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sims Portex, Inc.
- Date Received
- August 15, 2000
- Decision Date
- December 14, 2000
- Product Code
- CAH
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| CAH | Filter, Bacterial, Breathing-Circuit | FDA class 2 | Anesthesiology |
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Other Clearances by Sims Portex, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K011925 | HYPODERMIC NEEDLE-PRO NEEDLE WITH NEEDLE PROTECTION DEVICE; HYPODERMIC NEEDLE-PRO SYRINGE & NEEDLE WITH NEEDLE PROTECTIO | Jul 12, 2001 | Substantially Equivalent |
| K002201 | ELECTROSTATIC HYDROPHOBIC BREATHING FILTER | Feb 5, 2001 | Substantially Equivalent |
| K001318 | CPAP SYSTEM, MODEL 102001 | Jul 20, 2000 | Substantially Equivalent |
| K993619 | CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA SYSTEM WITH LOCK | Apr 28, 2000 | Substantially Equivalent |
| K994275 | SIMS PORTEX ANESTHESIA CATHETER | Feb 22, 2000 | Substantially Equivalent |
| K991861 | 1ST RESPONSE INFANT MANUAL RESUSCITATOR, BAG RESEVOIR, 1ST RESPONSE PEDIATRIC MANUAL RESUSCITATOR, BAG RESERVOIR, 1ST RE | Jan 18, 2000 | Substantially Equivalent |
| K992471 | SIMS PORTEX EPIDURAL CATHETER, 20G MODEL# 4910-16/17; 21G MODEL# 4910-18 | Oct 22, 1999 | Substantially Equivalent |
| K992057 | IST RESPONSE MANUAL RESUSCITATOR, MODELS, 008000, 008003,008006 | Sep 13, 1999 | Substantially Equivalent |
| K983858 | SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLES | Jan 29, 1999 | Substantially Equivalent |
| K981035 | PRO-VENT, PULSATOR ARTERIAL BLOOD SAMPLING SYRINGES | Apr 21, 1998 | Substantially Equivalent |