510(k) K103536
- Device
- IBED WIRELESS WITH IBED AWARENESS
- Applicant
- STRYKER CORPORATION
- 510(k) number
- K103536
- Product code
- FNL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-12-16
- Date received
- 2010-12-01
- Regulation
- 880.5100
- Classification name
- Bed, Ac-powered Adjustable Hospital
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- Yes
Applicant Contact#
- Contact
- Diane Horwitz
- Address
- 3800 E. Centre Ave. Portage MI US 49002 49002
FDA Registration Numbers#
- 3029995169
- 3012480128
- 3031700059
- 3012579728
- 3011277660
- 3017171467
- 3035641505
- 3001752600
- 3007913191
- 3011574775
- 3017278503
- 3010605276
- 3006802326
- 3006897028
- 3010411316
- 3009157571
- 3011687503
- 3006697241
- 3030522263
- 3010509576
- 3027847726
- 3011714211
- 3009402404
- 3006554924
- 3005179379
- 3013685983
- 3008058231
- 3017637606
- 3025460026
- 8043351
- 3043654660
- 3032597250
- 3013913556
- 3012274425
- 2648727
- 3006795832
- 3038381831
- 3016796135
- 3001708137
- 3008830652
- 3034729907
- 3007420694
- 3038613081
- 1000252066
- 1066270
- 3008386649
- 3014739961
- 3010452421
- 3009667418
- 3038277448
- 1320360
- 3005698350
- 3015131225
- 3045857302
- 1043214
- 3008771621
- 3015223105
- 3027614450
- 3035641086
- 3013524663
- 3003600763
- 3045978136
- 3036978609
- 1954156
- 3006513362
- 3010699203
- 3015286905
- 3021374638
- 3010373263
- 3016678414
- 3011659880
- 3043177791
- 3013875443
- 1824206
- 3030516433
- 3006891315
- 1062191
- 3011910987
- 3042262500
Source Documents#
Other 510(k) Records For Product Code FNL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K202964 | iBed Wireless with iBed Mobile | Stryker Corporation | 2021-06-18 |
| K982783 | VAIL 1000 ENCLOSED BED | Vail Products, Inc. | 1998-10-05 |
| K974296 | MODEL 720 SERIES FULL/SEMI ELECTRIC BED 1120 FULL ELECTRIC BED | Invacare Corp. | 1998-01-06 |
| K974254 | BENEFIT B3--- SERIES | M.C. Healthcare Products, Inc. | 1997-12-16 |
| K972115 | VOLKER HOSPITAL BED, MODEL K960 | Volker Healthcare, Inc. | 1997-08-29 |
| K971546 | SOMA 900 TRANSPORT BED | Nova Technologies, Inc. | 1997-07-10 |
| K963622 | VAIL 2000 ENCLOSED BED | Vail Products, Inc. | 1997-05-07 |
| K963589 | VAIL 3000 BED ENCLOSURE | Vail Products, Inc. | 1997-04-21 |
| K962942 | TOTALCARE | Hill-Rom, Inc. | 1997-02-03 |
| K963701 | SOMA SAFE ENCLOSURE | Nova Technology Corp. | 1997-01-24 |
| K964246 | NOVABED PATIENT TRANSFER SYSTEM | Nova Technology Corp. | 1997-01-22 |
| K964515 | ACCLAIM SERIES QD6000,QD6001,QD6002 AND SERIES QD3000,QD3001, QD3002 | M.C. Healthcare Products, Inc. | 1996-12-31 |
| K962250 | CARROLL HEALTHCARE DLX 2300-111 ELECTRIC BED | Carroll Healthcare, Inc. | 1996-10-21 |
| K962763 | 2000 MODULAR THIRTY-NINE | Equi-Tron Mfg., Inc. | 1996-10-07 |
| K951514 | SSC MODEL 4000 SERIES | Ssc Medical Products, Inc. | 1996-03-06 |
Legacy Summary#
summary
FDA Review#
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