FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
SIGMA ELITE
K Number: K942545
·
Decision Feb 3, 1995
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
56
Applicant Total
9
Review Days
248
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Basic Information
- Device Name
- SIGMA ELITE
- K Number
- K942545
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5880
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Penlon , Ltd.
- Date Received
- May 31, 1994
- Decision Date
- February 3, 1995
- Product Code
- CAD
- 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 |
|---|---|---|---|
| CAD | Vaporizer, Anesthesia, Non-Heated | FDA class 2 | Anesthesiology |
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Other Clearances by Penlon , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K061102 | PRIMA ANAESTHESIA MACHINE | Jul 28, 2006 | Substantially Equivalent |
| K041076 | DELTA T | Aug 9, 2004 | Substantially Equivalent |
| K010317 | AV 800 VENTILATOR | Jul 23, 2001 | Substantially Equivalent |
| K010318 | PRIMA OXYGEN MONITOR | Jul 23, 2001 | Substantially Equivalent |
| K002343 | SIGMA DELTA | Jun 8, 2001 | Substantially Equivalent |
| K961468 | QUIK-FIL VAPORIZER KEYED FILLER | Jul 16, 1996 | Substantially Equivalent |
| K960944 | PPV VAPORIZER (MODIFICATION) | Apr 2, 1996 | Substantially Equivalent |
| K953179 | CLM LARYNGOSCOPE | Oct 6, 1995 | Substantially Equivalent |