510(k) K101136
- Device
- FISIO CHAMBER SPACE
- Applicant
- KOO(SHANGHAI)INDUSTRIES CO., LTD.
- 510(k) number
- K101136
- Product code
- NVP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-01-28
- Date received
- 2010-04-22
- 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
Applicant Contact#
- Contact
- PAUL DRYDEN
- Address
- 24301 Woodsage Dr. Bonita Springs FL US 34134 34134
FDA Registration Numbers#
- 9615834
- 3023272766
- 1317346
- 3006411563
- 3002949731
- 9612777
- 3013037032
- 3029227324
- 3021244152
- 2518422
- 3010402691
- 1062191
- 3002797442
- 3007963782
- 3006446479
- 3010834934
- 3038562397
- 3005977696
- 2026894
- 3006061749
- 3007384659
- 3010131137
- 3018783526
- 9610639
- 3000126629
- 1314417
Source Documents#
Other 510(k) Records For Product Code NVP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242667 | AeroChamber2go Anti-Static Valved Holding Chamber | Trudell Medical International | 2025-01-15 |
| K210558 | LiteAire Basic Dual-Valved, Collapsible MDI Holding Chamber | Thayer Medical Corporation | 2022-04-01 |
| K181649 | AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC) | Trudell Medical International | 2019-01-11 |
| K160109 | Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber | Thayer Medical Corporation | 2017-05-19 |
| K143615 | Antistatic Compact Space Chamber | Medical Developments International Limited | 2016-01-26 |
| K140062 | FSC ANTI-STATIC VALVED COLLAPSIBLE HOLDING CHAMBER | Fsc Laboratories, Inc. | 2014-10-03 |
| K122252 | SPACE CHAMBER PLUS COMPACT SPACE CHAMBER PLUS | Medical Developments International | 2013-11-13 |
| K130598 | INSPIRACHAMBER ANTI-STATIC VALVED HOLDING CHAMBER | Inspirx, Inc. | 2013-06-05 |
| K112010 | AEROCHAMBER PLUS FLOW-VU ANTI-STATIC VALVED HOLDING CHAMBER (VHC) | Trudell Medical Intl. | 2012-07-11 |
| K110293 | OPTICHAMBER DIAMOND VALVED HOLDING CHAMBER | Respironics New Jersey, Inc. | 2011-08-09 |
| K101348 | AGACHAMBER SPACER | Aga Plastic Ind. Com. Ltda. | 2011-04-29 |
| K110136 | RESPICHAMBER VALVED HOLDING CHAMBER | Trudell Medical Intl. | 2011-04-18 |
| K080100 | WATCHHALER | Activaero America, Inc. | 2008-06-30 |
| K070674 | AEROCHAMBER PLUS ANTI-STATIC VALVED HOLDING CHAMBER WITH FLOW-VU INSPIRATORY FLOW INDICATOR | Trudell Medical Intl. | 2007-04-11 |
| K052332 | AEROCHAMBER Z-STAT PLUS VALVED HOLDING CHAMBER | Trudell Medical Intl. | 2005-09-21 |
Legacy Summary#
summary
FDA Review#
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