510(k) K990574
- Device
- Stick-on Disposable Nasal Mask, Model 312174, 1001964
- Applicant
- RESPIRONICS, INC.
- 510(k) number
- K990574
- Product code
- MNT
- Decision
- Substantially Equivalent - Subject to Tracking Reg. (ST)
- Decision date
- 1999-05-24
- Date received
- 1999-02-23
- Regulation
- 868.5895
- Classification name
- Sv70 Ventilator
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVID J VANELLA
- Address
- 1001 Murry Ridge Ln. Murrysville PA US 15668 15668
FDA Registration Numbers#
- 3004604967
- 3007603826
- 3033526676
- 3009156722
- 8010042
- 3023272766
- 3006783791
- 3008264065
- 3011120183
- 3001400310
- 3004428458
- 3010817335
- 3013154126
- 3029227324
- 2518422
- 3013190994
- 2085602
- 3002797442
- 3038562397
- 3007573469
- 3014631252
- 9611451
- 9617566
- 3020283264
- 3018783526
- 3000126629
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code MNT#
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| K103167 | STELLAR 150 | Resmed Germany, Inc. | 2011-03-01 |
| K090113 | BREAS VIVO 40 SYSTEM | Breas Medical AB | 2009-05-14 |
| K082660 | V60 VENTILATOR, MODEL V8000 | Respironics California, Inc. | 2009-01-09 |