The following data is part of a premarket notification filed by Huntleigh Healthcare with the FDA for Dopplex Ability.
| Device ID | K121108 |
| 510k Number | K121108 |
| Device Name: | DOPPLEX ABILITY |
| Classification | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic |
| Applicant | HUNTLEIGH HEALTHCARE 35 PORTMANMOOR ROAD Cardiff, GB Cf24 5hn |
| Contact | David Moynham |
| Correspondent | David Moynham HUNTLEIGH HEALTHCARE 35 PORTMANMOOR ROAD Cardiff, GB Cf24 5hn |
| Product Code | JOM |
| CFR Regulation Number | 870.2780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-12 |
| Decision Date | 2013-01-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051968030511 | K121108 | 000 |
| 05051968030030 | K121108 | 000 |
| 05051968030337 | K121108 | 000 |
| 05051968030344 | K121108 | 000 |
| 05051968030351 | K121108 | 000 |
| 05051968030368 | K121108 | 000 |
| 05051968030375 | K121108 | 000 |
| 05051968030412 | K121108 | 000 |
| 05051968030429 | K121108 | 000 |
| 05051968030436 | K121108 | 000 |
| 05051968030474 | K121108 | 000 |
| 05051968030481 | K121108 | 000 |
| 05051968030498 | K121108 | 000 |
| 05051968030504 | K121108 | 000 |
| 05051968035370 | K121108 | 000 |