510(k) K984124
- Device
- AESCULAP XENON LIGHT SOURCE
- Applicant
- AESCULAP, INC.
- 510(k) number
- K984124
- Product code
- FSS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-02-01
- Date received
- 1998-11-18
- Regulation
- 878.4580
- Classification name
- Light, Surgical, Floor Standing
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARY ELLEN HOLDEN
- Address
- 1000 Gateway Blvd. South San Francisco CA US 94080 94080
FDA Registration Numbers#
- 3011580044
- 3012165496
- 1066635
- 3031700059
- 9710055
- 3015131225
- 1836161
- 9610612
- 1035968
- 3009542956
- 3030516433
- 8010153
- 2916714
- 3025628903
- 3042992004
- 3011644607
- 3042989733
- 1825014
- 3017884063
- 1066270
- 3007123908
- 3021559257
- 3035641086
- 3027847726
- 1043572
- 3006223081
- 3015223105
- 3007591382
- 8030607
- 2936485
- 3003574554
- 9681407
- 3005698350
- 3020703842
- 3007143268
- 3006437518
- 3031563141
Source Documents#
Other 510(k) Records For Product Code FSS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K091246 | ILED 3 MOBILE (I300M), TRULIGHT 5500 MOBILE (T500M), TRULIGHT 5300 MOBILE (T300M) | Trumpf Medizin Systeme GmbH + Co. KG | 2009-09-28 |
| K003489 | NEXT GENERAL M20 SURGICAL LIGHT; NEXT GENERATION M16 MINOR SURGERY LIGHT; NEXT GENERATION SPOTLIGHT; NEXT GENERATION M8 | Medical Illumination International, Inc. | 2001-02-02 |
| K981962 | CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCE | Cuda Products Co. | 1998-08-18 |
| K981821 | VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATOR | Angiolaz, Inc. | 1998-07-29 |
| K981469 | CERMAX300 LIGHTSOURCE | Cuda Products Co. | 1998-07-09 |
| K980044 | XENON 300MX | Perkinelmer Optoelectronics | 1998-04-03 |
| K970886 | HANAULUX BLUE 80 HOSPITAL | Heraeus Med GmbH | 1997-04-16 |
| K961971 | Q-5000 | Stryker Endoscopy | 1996-06-28 |
| K961074 | LIGHTSOURCE OR ILLUMINATOR | Cuda Products Co. | 1996-04-30 |
| K930711 | TRI*STAR | Light Technology Systems | 1993-07-30 |
| K910942 | AC POWERED AND BATTERY POWERED MEDICAL EXAM. LIGHT | Mdt Biologic Co. | 1991-06-11 |
| K895950 | MODEL FEL5100 FLOOR LIGHT | F.W. Lang Co. | 1989-10-31 |
| K893813 | FLOOR STANDING, OPERATING AND EXAMINING LIGHT | Astralite Corp. | 1989-07-14 |
| K891758 | KINETIC MODEL 132 | Kinetic Biomedical Services, Inc. | 1989-04-19 |
| K891759 | KINETIC MODEL 330 | Kinetic Biomedical Services, Inc. | 1989-04-19 |
Legacy Summary#
summary
FDA Review#
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