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 |