510(k) K240598
- Device
- Maestro System (REF100)
- Applicant
- Moon Surgical
- 510(k) number
- K240598
- Product code
- FQO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-06-03
- Date received
- 2024-03-04
- Regulation
- 878.4960
- Classification name
- Table, Operating-Room, Ac-Powered
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Anne Osdoit
- Address
- 9 Rue D’Enghien Paris FR 75010 75010
FDA Registration Numbers#
- 3004137296
- 3037012186
- 3009028104
- 3011580044
- 3007014520
- 9680168
- 3029970239
- 9611500
- 8021896
- 2183744
- 3019878714
- 1054713
- 3011910987
- 1000122786
- 1643116
- 9610612
- 3010037894
- 3010373263
- 3006142326
- 3003786160
- 3010673832
- 3015978022
- 3014739961
- 2921578
- 3006467297
- 3003477135
- 3003768277
- 3010326005
- 3006105501
- 2031963
- 3007055152
- 3042471748
- 1033902
- 3017847344
- 3026790309
- 8010652
- 1825014
- 3010373494
- 3007836437
- 3035641086
- 3027847726
- 1043572
- 3021839632
- 3017181414
- 2518443
- 3012272052
- 3003950207
- 3035111606
- 3015223105
- 3007591382
- 3010373530
- 1047843
- 2936485
- 3005285078
- 3007682310
- 3008786200
- 3013522950
- 3002807616
- 3023808059
- 3006800085
- 2030380
- 3005698350
- 3013685983
- 2221819
- 1066427
- 2027467
- 3043654660
- 3031563141
- 3012708860
Source Documents#
Other 510(k) Records For Product Code FQO#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K221410 | Maestro Platform | Moon Surgical | 2022-12-02 |
| K090136 | STERIS CMAX XLT SURGICAL TABLE | STERIS Corporation | 2009-03-20 |
| K972810 | OPT80 THE TRANSPORTABLE (OPT80) | O.P.T. USA, Inc. | 1997-08-26 |
| K971988 | ALLEN, ULTRA AND SMART SOCKETS | Allen Medical Systems, Inc. | 1997-07-11 |
| K971307 | AMSCO SURGICAL TABLE | STERIS Corporation | 1997-06-27 |
| K963506 | TENET RADIOLUCENT HAND TABLE | Tenet Medical Engineering | 1997-01-09 |
| K961886 | DRAGER GEMINA WALL-MOUNTED WORKPLACE | Alm Surgical Equipment, Inc. | 1996-07-30 |
| K961742 | DRAGER DVE 8080/81/82 WITH DVE 4002 OR DVE 4001 SERIES SYSTEM | Alm Surgical Equipment, Inc. | 1996-07-26 |
| K955750 | TELETOM | Berchtold Holding GmbH | 1996-02-08 |
| K953980 | KREUZER CEILING MOUNTED SUPPORT SYSTEMS, KLINOPORT | Kreuzer Corp. | 1995-11-16 |
| K951854 | LEONARD ARM - SUPPORT ARM - ENDOSCOPIC ACCESSORY | Leonard Medical, Inc. | 1995-06-21 |
| K950192 | SKYTRON SKYBOOM SERIES | Skytron, Div. the Kmw Group, Inc. | 1995-04-03 |
| K926463 | RITTERMODEL 75 EVOLUTION UNIV POW EXAM TABLE/ACCES | Midmark Corp. | 1994-10-21 |
| K942486 | IMAGE FULL POWER EXAMINATION/MINOR SURGERY TABLE | Mdt Corp., Inc. | 1994-08-10 |
| K942043 | DRAGER DVE 8000/1/2 SERIES SYST W/DVE 4002 AND 8032E | Alm Surgical Equipment, Inc. | 1994-07-13 |