Respironics Inc., Sleep & Home Respiratory Group
Murrysville, PA, US
Respironics Inc., Sleep & Home Respiratory Group appears in FDA device records in Murrysville, PA. FDA records list 21 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 21
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 21 510(k) clearances for Respironics Inc., Sleep & Home Respiratory Group between 2007 and 2010. The busiest year on record is 2009, with 13. The most recent is 2010, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2007 | 6 |
| 2008 | 1 |
| 2009 | 13 |
| 2010 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K092835 | COMFORTGEL NASAL MASK | BZD | Substantially Equivalent | |
| K092648 | RESPIRONICS PERFORMAX SE TOTAL FACE MASK | CBK | Substantially Equivalent | |
| K090539 | BIPAP AUTOSV ADVANCED | MNS | Substantially Equivalent | |
| K091191 | GAS TRANSFILL | CAW | Substantially Equivalent | |
| K091843 | COMFORT TWIN NASAL MASK | BZD | Substantially Equivalent | |
| K091066 | COMFORT TWIN NASAL MASK | BZD | Substantially Equivalent | |
| K091319 | REMSTAR AUTO A-FLEX | BZD | Substantially Equivalent | |
| K090484 | ALICE PDX | MNR | Substantially Equivalent | |
| K091271 | RESPIRONICS PERFORMAX TOTAL FACE MASK | BZD | Substantially Equivalent | |
| K090243 | REMSTAR M-SERIES AUTO WITH AFLEX CPAP SYSTEM | BZD | Substantially Equivalent | |
| K083526 | TRILOGY 100 VENTILATOR | CBK | Substantially Equivalent | |
| K090248 | BIPAP AUTOSV | MNS | Substantially Equivalent | |
| K082866 | REVOLUTIONFULL FACE MASK | BZD | Substantially Equivalent | |
| K083874 | GALAXY | MNR | Substantially Equivalent | |
| K073600 | COMFORTGEL FULL FACE MASK | BZD | Substantially Equivalent | |
| K072592 | PERFORMAX TOTAL FACE MASK | BZD | Substantially Equivalent | |
| K072588 | PERFORMAX SE TOTAL FACE MASK | CBK | Substantially Equivalent | |
| K071509 | BIPAP SYNCHRONY 2 VENTILATORY SUPPORT SYSTEM | MNS | Substantially Equivalent | |
| K070180 | WALLABY 4 | LBI | Substantially Equivalent | |
| K070328 | BIPAP SYNCHRONY WITH AVAPS | MNS | Substantially Equivalent | |
| K063830 | REMSTAR AFLEX CPAP SYSTEM | BZD | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain