510(k) K893643
- Device
- NOVAMETRIX MDLS 500A, 505A, 515A, & 7000A OXIMETER
- Applicant
- NOVAMETRIX MEDICAL SYSTEMS, INC.
- 510(k) number
- K893643
- Product code
- DQA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-10-26
- Date received
- 1989-05-15
- Regulation
- 870.2700
- Classification name
- Oximeter
- Medical specialty
- Cardiovascular
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- H SCHIFFMAN
- Address
- 1 Barnes Industrial Park Rd. P.O. Box 690 Wallingford CT US 06492 06492
FDA Registration Numbers#
- 3013826848
- 8022257
- 3011420269
- 3001104093
- 3010536822
- 3008573045
- 3010984687
- 3006182632
- 3044675072
- 3000279201
- 3004415095
- 3013679558
- 3023412068
- 1058397
- 1218950
- 3021131596
- 8020893
- 3009001657
- 3004102403
- 3018783553
- 3016426850
- 3003971136
- 3007583504
- 3017059349
- 3020018
- 3006147705
- 3001650535
- 3044754336
- 9617543
- 3003832357
- 3010703925
- 3010838917
- 3011651103
- 8044004
- 3008733163
- 3003674698
- 2030745
- 3007858728
- 3008164770
- 3027344406
- 2022648
- 3003800159
- 1320894
- 3030153385
- 3015529350
- 3014461810
- 3013500228
- 1000122786
- 9610849
- 3026740087
- 3008570547
- 9614500
- 3010552191
- 3034405508
- 3005873568
- 1217183
- 3008395508
- 3032391
- 3023272766
- 2518422
- 3010852191
- 2016493
- 3006552505
- 3032109181
- 3010157426
- 3010317211
- 3013557562
- 1423537
- 3015109923
- 3007307487
- 3009490946
- 2081040
- 3015453963
- 2936999
- 3036754877
- 3000206696
- 3004009431
- 3044156918
- 3016674095
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DQA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252821 | Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T) | Philips Medizin Systeme Böblingen GmbH | 2026-05-29 |
| K252655 | Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT) | Shenzhen Imdk Medical Technology Co., Ltd. | 2026-05-11 |
| K253887 | Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401) | Philips Medizin Systeme | 2026-05-01 |
| K260931 | Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R) | Unimed Medical Supplies, Inc. | 2026-04-14 |
| K252448 | AViTA Pulse Oximeter (SP61) | Avita Corporation | 2026-02-27 |
| K252805 | YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2026-02-17 |
| K253109 | Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O) | Shenzhen Best Electronics Co., Ltd. | 2026-01-07 |
| K251751 | Spo2 Sensor CSS032D | Shenzhen Ykd Technology Co., Ltd. | 2025-12-19 |
| K251691 | Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U203S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103-08) | Unimed Medical Supplies, Inc. | 2025-12-01 |
| K251696 | Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-29) | Unimed Medical Supplies, Inc. | 2025-12-01 |
| K251693 | Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110-75); Unimed Reusable SpO2 Sensors (-75 Series) (U410S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U210S-75) | Unimed Medical Supplies, Inc. | 2025-11-18 |
| K251695 | Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U203S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U103S-06) | Unimed Medical Supplies, Inc. | 2025-11-18 |
| K250837 | Pulse Oximeter | Shanghai Berry Electronic Tech Co., Ltd. | 2025-09-25 |
| K250931 | Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U103-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U410-121); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U110-121) | Unimed Medical Supplies, Inc. | 2025-08-13 |
| K241086 | Avidhrt Sense SpO2 | Avidhrt, Inc. | 2025-05-09 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases