SIGMA ELITE
Vaporizer, Anesthesia, Non-heated
PENLON LTD.
The following data is part of a premarket notification filed by Penlon Ltd. with the FDA for Sigma Elite.
Pre-market Notification Details
| Device ID | K942545 |
| 510k Number | K942545 |
| Device Name: | SIGMA ELITE |
| Classification | Vaporizer, Anesthesia, Non-heated |
| Applicant | PENLON LTD. ABINGDON OX 14 3PH Abingdon Ox, GB |
| Contact | A. C Green |
| Correspondent | A. C Green PENLON LTD. ABINGDON OX 14 3PH Abingdon Ox, GB |
| Product Code | CAD |
| CFR Regulation Number | 868.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-31 |
| Decision Date | 1995-02-03 |
Trademark Results [SIGMA ELITE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SIGMA ELITE 85665500 4345613 Live/Registered |
Perry Baromedical Corp. 2012-06-29 |
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