510(k) K951161
- Device
- MC ACCLAIM Q6000 BED
- Applicant
- JANCO CONSULTING SERVICES
- 510(k) number
- K951161
- Product code
- FNL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-05-09
- Date received
- 1995-03-14
- 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
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- JANET SHAW
- Address
- 6839 Montevideo Rd. Mississauga, Ontario L5n 1n7 CA L5N 1N7 L5N 1N7
FDA Registration Numbers#
- 3042989733
- 3045857735
- 3008830652
- 3012392312
- 3011714211
- 3011574775
- 3011908389
- 3017642731
- 1000252066
- 3044829820
- 3006554924
- 9681454
- 3010034871
- 3038141559
- 3005706637
- 3006897028
- 2080309
- 3010605276
- 3014498763
- 3010452421
- 1317511
- 3001708137
- 3026311463
- 3015967131
- 3034602341
- 3043177791
- 3006206434
- 3017278503
- 3039346864
- 3038277448
- 3030681105
- 3008881803
- 3010509576
- 3014810929
- 1422399
- 3002713667
- 3015131225
- 3042970964
- 3003770834
- 3038381831
- 3010699203
- 3005437748
- 3011621895
- 3021374638
- 1000122786
- 3037012186
- 3043178571
- 3008975187
- 3010411316
- 3015158050
- 3007744192
- 3012316249
- 3010373530
- 1417592
- 3018771894
- 3004186402
- 1831750
- 3014471045
- 3009157571
- 3016678414
- 3043088159
- 3027332478
- 1954156
- 1931947
- 3016678950
- 1054713
- 3025024261
- 3017079526
- 3002821232
- 3029995169
- 3014926188
- 3013913556
- 3040337865
- 3014101053
- 3015969549
- 3015286905
- 3013524663
- 3014523858
- 3004976058
Source Documents#
510(k) summary PDF not indicated by FDA
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 |
| K103536 | IBED WIRELESS WITH IBED AWARENESS | Stryker Corporation | 2010-12-16 |
| 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 |
Legacy Summary#
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FDA Review#
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