The following data is part of a premarket notification filed by Penlon Ltd. with the FDA for Sigma Delta.
| Device ID | K002343 |
| 510k Number | K002343 |
| Device Name: | SIGMA DELTA |
| Classification | Vaporizer, Anesthesia, Non-heated |
| Applicant | PENLON LTD. Abingdon Science Park Barton Lane, Abingdon, GB Ox14 3nb |
| Contact | Anthony Parsons |
| Correspondent | Anthony Parsons PENLON LTD. Abingdon Science Park Barton Lane, Abingdon, GB Ox14 3nb |
| Product Code | CAD |
| CFR Regulation Number | 868.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-01 |
| Decision Date | 2001-06-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051977000536 | K002343 | 000 |
| 05051977000116 | K002343 | 000 |
| 05051977002042 | K002343 | 000 |
| 05051977002035 | K002343 | 000 |
| 05051977002028 | K002343 | 000 |
| 05051977002011 | K002343 | 000 |
| 05051977001465 | K002343 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SIGMA DELTA 75232121 not registered Dead/Abandoned |
MONSTER CABLE INTERNATIONAL, LTD. 1997-01-28 |
![]() SIGMA DELTA 75070397 not registered Dead/Abandoned |
ProfiTEX Advisors, Ltd 1996-03-11 |