510(k) K092903
- Device
- BORA UP 2080, BORA UP 2080 OP AND BORA UP 2080 MOUNTING
- Applicant
- MAQUET GMBH AND CO. KG
- 510(k) number
- K092903
- Product code
- BTA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-12-01
- Date received
- 2009-09-21
- Regulation
- 878.4780
- Classification name
- Pump, Portable, Aspiration (manual Or Powered)
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- Yes
Applicant Contact#
- Contact
- ANNETTE JAKOB
- Address
- Kehler Strasse 31 Rastatt De-Bw DE 76437 76437
FDA Registration Numbers#
- 2024022
- 3005813597
- 3042507287
- 9610612
- 3010659128
- 3002807523
- 3017435705
- 3005527904
- 3007305485
- 3016591327
- 3011050570
- 3005146144
- 3010202439
- 2032112
- 3013857114
- 9680741
- 8010573
- 3015177409
- 3017520736
- 3009538961
- 3011816507
- 9610861
- 3004727197
- 9614434
- 2134752
- 9617787
- 1419937
- 3011716786
- 3004378299
- 1649660
- 9617543
- 3005168196
- 3003781173
- 3026986849
- 3009039068
- 9611174
- 2020550
- 3006142527
- 3014827316
- 3004050971
- 3038634684
- 1220908
- 3029871637
- 1450908
- 9680961
- 2022724
- 1060680
- 3016904853
- 3023876581
- 1043214
- 3016661562
- 3006174295
- 3004993040
- 3013095415
- 3010034780
- 3006617533
- 3013298431
- 3019924
- 1417592
- 1219343
- 3007360714
- 2523148
- 3003509351
- 1000604079
- 3008837339
- 1924066
- 3004145393
- 3014718111
- 3013556777
- 3021595514
- 3042156936
- 3014273557
- 3004464325
- 3015924074
- 2132111
- 1000122786
- 3031563234
- 3012322232
- 3005803793
- 3006789357
Source Documents#
Other 510(k) Records For Product Code BTA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260134 | Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021) | Shenzhen Root Innovation Technology Co., Ltd. | 2026-05-15 |
| K260892 | Suction Pump (SU-90) | Shenzhen HugeMed Medical Technical Development Co., Ltd. | 2026-05-14 |
| K260473 | Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B) | Shenzhen Kingboom Technology Co., Ltd. | 2026-05-12 |
| K253107 | Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90) | Shenzhen Dongjiang Technology Co., Ltd. | 2026-04-14 |
| K260147 | Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036) | Shenzhen Kingboom Technology Co., Ltd. | 2026-03-13 |
| K251450 | Baby Nasal Aspirator (BN002); Baby Nasal Aspirator (BN006); Baby Nasal Aspirator (BN007); Baby Nasal Aspirator (BN008); Baby Nasal Aspirator (BN009) | Shenzhen Desida Technology Co., Ltd. | 2025-06-06 |
| K244033 | Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610) | Shenzhen Desida Technology Co., Ltd. | 2025-05-16 |
| K251101 | AIRO Suction Unit (AIRO-01) | Cro, LLC | 2025-04-26 |
| K250697 | Electric Nasal Aspirator (BC026, BC025, BC023) | Shenzhen Kingboom Technology Co., Ltd. | 2025-04-23 |
| K241799 | ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (317.1300.0); Hose system (312.1177.0); Hose system with connector small (312.1206.0); Hose system with connector medium (312.1207.0); Hose system with connector large (312.1208.0); Hose system with Y-connector medium (312.1209.0); Hose system with Y-connector large (312.1210.0); Universal bracket for ATMOS C 051 Thorax (316.0200.0); Bracket for ATMOS C 051 Thorax - Standard rail (317.1160.0); Charger Storage for bracket ATMOS C | Atmos Medizintechnik GmbH & Co. KG | 2025-03-07 |
| K243138 | Geon (S2) Nasal Aspirator | Geon Corporation | 2025-02-04 |
| K241852 | Nasal Aspirator (NS 13) | Avita Corporation | 2024-12-31 |
| K242028 | Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026) | Dongguanshi Yiyingmei Technology Co., Ltd. | 2024-11-19 |
| K241202 | Electric nasal aspirator (HTD2601US) | Hetaida Technology Co., Ltd. | 2024-07-01 |
| K233901 | Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006, NASA008, NASA009) | Shenzhen Desida Technology Co., Ltd. | 2024-03-20 |
Legacy Summary#
summary
FDA Review#
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