510(k) K110293
- Device
- OPTICHAMBER DIAMOND VALVED HOLDING CHAMBER
- Applicant
- RESPIRONICS NEW JERSEY, INC.
- 510(k) number
- K110293
- Product code
- NVP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-08-09
- Date received
- 2011-02-01
- Regulation
- 868.5630
- Classification name
- Holding Chambers, Direct Patient Interface
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Lauren Ziegler
- Address
- 5 Wood Hollow Rd. Parsippany NJ US 07054 07054
FDA Registration Numbers
- 3007963782
- 3002797442
- 3006061749
- 3002949731
- 1062191
- 3006411563
- 3010402691
- 3007384659
- 3000126629
- 3029227324
- 3013037032
- 3010834934
- 9615834
- 9612777
- 9610639
- 2026894
- 1317346
- 2518422
- 3018783526
- 3005977696
- 3010131137
- 3023272766
- 1314417
- 3006446479
- 3021244152
- 3038562397
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00383730003917 | OPTICHAMBER DIAMOND | RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD | 2017-05-12 |
| 00383730003900 | OPTICHAMBER DIAMOND | RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD | 2017-05-12 |
| 00383730003924 | OPTICHAMBER DIAMOND | RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD | 2017-05-12 |
| 00383730000190 | OPTICHAMBER DIAMOND | RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD | 2016-08-24 |
| 00383730000206 | OptiChamber Diamond | RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD | 2016-08-24 |
| 00383730000213 | OPTICHAMBER DIAMOND | RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD | 2016-08-24 |
| 00383730000220 | OptiChamber Diamond | RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD | 2016-08-24 |
| 00383730000244 | OptiChamber Diamond | RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD | 2016-08-24 |
| 00383730000251 | OPTICHAMBER DIAMOND | RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD | 2016-08-24 |
| 00383730000336 | OPTICHAMBER DIAMOND | RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD | 2016-08-24 |
| 00383730000343 | OPTICHAMBER DIAMOND | RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD | 2016-08-24 |
| 00383730000350 | OPTICHAMBER DIAMOND | RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD | 2016-08-24 |
| 00383730000374 | OPTICHAMBER DIAMOND | RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD | 2016-08-24 |
| 00383730000381 | OPTICHAMBER DIAMOND | RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD | 2016-08-24 |
| 00383730000503 | OptiChamber Diamond | RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD | 2016-08-24 |
| 00383730000510 | OptiChamber Diamond | RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD | 2016-08-24 |
| 00383730000527 | OptiChamber Diamond | RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD | 2016-08-24 |
Legacy Summary
summary
FDA Review
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