Battery Pack #1005NC
FDA 510(k) K931348 · Portable Power Systems, Inc.
510(k) numberK931348
Submission
- Device name
- Battery Pack #1005NC
- Applicant
- Portable Power Systems, Inc.
Castle Rock, CO, US - Received
- March 17, 1993
- Decision date
- February 17, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- BTA – Pump, Portable, Aspiration (Manual Or Powered)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4780
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code BTA
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|---|---|---|---|
| K253629 | Momcozy Nasal Aspirator (BN007)BTA · Traditional | Shenzhen Root Innovation Technology Co., Ltd. | 05/26/2026SE |
| K260134 | Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A…BTA · Traditional | Shenzhen Root Innovation Technology Co., Ltd. | 05/15/2026SE |
| K260892 | Suction Pump (SU-90)BTA · Traditional | Shenzhen HugeMed Medical Technical Development… | 05/14/2026SE |
| K260473 | Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B)BTA · Traditional | Shenzhen Kingboom Technology Co., Ltd. | 05/12/2026SE |
| K253107 | Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)BTA · Traditional | Shenzhen Dongjiang Technology Co., Ltd. | 04/14/2026SE |
| K260147 | Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036)BTA · Traditional | Shenzhen Kingboom Technology Co., Ltd. | 03/13/2026SE |
| K251450 | Baby Nasal Aspirator (BN002); Baby Nasal Aspirator (BN006); Baby Nasal Aspirator…BTA · Special | Shenzhen Desida Technology Co., Ltd. | 06/06/2025SE |
| K244033 | Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610)BTA · Traditional | Shenzhen Desida Technology Co., Ltd. | 05/16/2025SE |
| K251101 | AIRO Suction Unit (AIRO-01)BTA · Traditional | Cro, LLC | 04/26/2025SE |
| K250697 | Electric Nasal Aspirator (BC026, BC025, BC023)BTA · Traditional | Shenzhen Kingboom Technology Co., Ltd. | 04/23/2025SE |
More from Shenzhen Kingboom Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K970234 | Sealed Lead Acid Battery PackIZL · Traditional | 05/02/1997SE |
| K946080 | Physio Control Lifepak 200 Auto DefibrillatorFCO · Traditional | 08/02/1995SE |
| K945043 | Battery Pack #PMX120-18AIZL · Traditional | 01/20/1995SE |
| K934508 | Battery Pack# S1024NCLDD · Traditional | 02/17/1994SE |
| K934439 | Rechargeable Battery Pack for Critikon 8100 Vital Signs MonitorDPS · Traditional | 02/17/1994SE |
| K934015 | Recharge Replace Battery PK Spacelabs 4045 Mon/DefibLDD · Traditional | 02/17/1994SE |
| K933065 | Battery Pack# S1009LADPS · Traditional | 02/17/1994SE |
| K932823 | Battery Pack# S1018LA for Ivac 4000, 4200 Vital CheckDXN · Traditional | 02/17/1994SE |
| K931484 | Replacement Batter for Abbott Labs Lifecare 4100 SBZD · Traditional | 02/17/1994SE |
| K931483 | Replacement Batery for GE AMX-4 Port. X-Ray Mach.IZL · Traditional | 02/17/1994SE |
Questions and answers
When was Battery Pack #1005NC cleared by the FDA?
Battery Pack #1005NC (K931348) received a 510(k) decision of Substantially Equivalent on February 17, 1994, 337 days after the submission was received.
What is the product code of K931348?
The FDA product code is BTA – Pump, Portable, Aspiration (Manual Or Powered), a Class II (moderate risk) device regulated under 21 CFR 878.4780.