The following data is part of a premarket notification filed by Penlon Ltd. with the FDA for Quik-fil Vaporizer Keyed Filler.
| Device ID | K961468 |
| 510k Number | K961468 |
| Device Name: | QUIK-FIL VAPORIZER KEYED FILLER |
| Classification | Vaporizer, Anesthesia, Non-heated |
| Applicant | PENLON LTD. ABINGDON Oxfordshire, GB Ox14 3ph |
| Contact | Alan C Green |
| Correspondent | Alan C Green PENLON LTD. ABINGDON Oxfordshire, GB Ox14 3ph |
| Product Code | CAD |
| CFR Regulation Number | 868.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-17 |
| Decision Date | 1996-07-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051977001595 | K961468 | 000 |