510(k) K991458
- Device
- MECA WRIST BLOOD PRESSURE METER, MODEL EW243 AND MODEL EW254
- Applicant
- MATSUSHITA ELECTRIC CORP. OF AMERICA
- 510(k) number
- K991458
- Product code
- DXN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-04-10
- Date received
- 1999-04-26
- Regulation
- 870.1130
- Classification name
- System, Measurement, Blood-pressure, Non-invasive
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- EDWARD M BASILE
- Address
- 1730 Pennsylvania Ave., NW Washington DC US 20006 20006
FDA Registration Numbers#
- 3008293988
- 3008717264
- 3010852191
- 3007703436
- 8020616
- 3003263092
- 3032916632
- 3007583504
- 3011420269
- 3010419931
- 3003950102
- 3015997711
- 2081040
- 3031158
- 3022418645
- 3012840029
- 3024512705
- 3036999955
- 3014579161
- 3045076243
- 3022764531
- 3013319763
- 9611295
- 3007740533
- 3019470217
- 3035375122
- 3004009431
- 1054713
- 3017424877
- 3035111606
- 3010082909
- 3006087789
- 3043226252
- 3006979678
- 3005735282
- 3005798905
- 3021282523
- 9710654
- 1018233
- 1219324
- 3013826848
- 1832894
- 3011721071
- 3033482477
- 3003971136
- 3005569927
- 3013426279
- 3008264255
- 3012302888
- 3004987887
- 3005621440
- 1450057
- 3021635975
- 3012312061
- 3013729860
- 9611045
- 3008011951
- 3010288146
- 8030476
- 1220908
- 3016630774
- 9610105
- 1216677
- 3012494290
- 3003993690
- 3034603279
- 3019130
- 3024790242
- 3003193933
- 3026753375
- 3009617411
- 3022946813
- 3016701404
- 3022147580
- 3020115
- 3037007069
- 3001373226
- 3011191255
- 3011359729
Source Documents#
Other 510(k) Records For Product Code DXN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253124 | Upper arm electronic blood pressure monitor (XB-01) | Shenzhen Ziqing Medical Equipment Co., Ltd. | 2026-06-03 |
| K253570 | Blood Pressure Monitor (W06LT) | Shenzhen Jamr Technology Co., Ltd. | 2026-05-20 |
| K254048 | Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T) | Shenzhen Urion Technology Co., Ltd. | 2026-05-14 |
| K253152 | BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000) | Biozen, LLC | 2026-05-06 |
| K260260 | Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521, LD-527, LD-572 & LD-569) | Honsun (Nantong) Co., Ltd. | 2026-04-28 |
| K252501 | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62E3B, DBP-62E2B, DBP-62E1B, DBP-61E3, DBP-61E2, DBP-61E1, DBP-61D7G, DBP-6281L, DBP-6282L, DBP-6285L) | Joytech Healthcare Co. , Ltd. | 2026-04-28 |
| K253982 | Korotkoff sound blood pressure monitor | Beijing Hanvon Health Technology Co., Ltd. | 2026-04-21 |
| K260276 | Arm Blood Pressure Monitor Models: ARM-30C+; ARM-30M+; ARM-HA101+; ARM-3060; XS Pro; ARM-30G1; ARM-30H; Visomat double comfort; Visomat comfort 20/40 BT; ARM-3080; ARM-3081; ARM-3082; ARM-3103; ARM-3200; ARM-115; ARM-111; ARM-3102; ARM-3100; ARM-3101; SBM 15; ARM-30W; ARM-30J; ARM-30F-XL; ARM-3024-XL; ARM-3025-XL; ARM-3062-XL; 9S Pro | Shenzhen AOJ Medical Technology Co., Ltd. | 2026-04-01 |
| K254225 | Arm Blood Pressure Monitor (HH-802CB, HH-802EB, HH-805CB, HH-812CB, HH-808CL, HH-808EL) | Shenzhen HanHan Technology Co., Ltd. | 2026-04-01 |
| K260273 | Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C Pro,U90C Plus,U90C Ultra).) | Shenzhen Urion Technology Co., Ltd. | 2026-03-26 |
| K252779 | YUWELL® Electronic Blood Pressure Monitor (YE630CR) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2026-03-05 |
| K253228 | YUWELL® Electronic Blood Pressure Monitor (YE650AR) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2026-02-23 |
| K253133 | Wrist Blood Pressure Monitor (BPM-W1VL) | Shenzhen Imdk Medical Technology Co., Ltd. | 2026-02-13 |
| K252685 | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P, DBP-63D2L, DBP-63D2L-P, DBP-61D9L,DBP-61D9L-P, DBP-63D9L, DBP-63D9L-P, DBP-62F4L, DBP-62F4B, DBP-61F4,DBP-61F4L, DBP-61F4-P, DBP-61F4L-P, DBP-62F4L-P, DBP-62F4B-P) | Joytech Healthcare Co. , Ltd. | 2026-02-13 |
| K251581 | Wearable Ambulatory Blood Pressure Monitor (WBP-02A) | Shenzhen Hingmed Medical Instrument Co., Ltd. | 2026-02-13 |
Legacy Summary#
summary
FDA Review#
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