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 |
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 |