The following data is part of a premarket notification filed by Codonics, Inc. with the FDA for Codonics Safe Labeling System (sls), Model 500i/500p.
| Device ID | K101439 |
| 510k Number | K101439 |
| Device Name: | CODONICS SAFE LABELING SYSTEM (SLS), MODEL 500I/500P |
| Classification | Gas-machine, Anesthesia |
| Applicant | CODONICS, INC. 17991 ENGLEWOOD DR. Middleburg Heights, OH 44130 |
| Contact | Gary W Enos |
| Correspondent | Gary W Enos CODONICS, INC. 17991 ENGLEWOOD DR. Middleburg Heights, OH 44130 |
| Product Code | BSZ |
| CFR Regulation Number | 868.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-24 |
| Decision Date | 2011-02-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814905020823 | K101439 | 000 |
| 00814905020007 | K101439 | 000 |
| 00814905020014 | K101439 | 000 |
| 00814905020021 | K101439 | 000 |
| 00814905020038 | K101439 | 000 |
| 00814905020137 | K101439 | 000 |
| 00814905020144 | K101439 | 000 |
| 00814905020229 | K101439 | 000 |
| 00814905020236 | K101439 | 000 |
| 00814905020243 | K101439 | 000 |
| 00814905020250 | K101439 | 000 |
| 00814905020366 | K101439 | 000 |
| 00814905020373 | K101439 | 000 |
| 00814905021103 | K101439 | 000 |